Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial.

BACKGROUND: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device-host interactions. AIMS: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self-expanding supra-annular transcatheter heart valve. METHODS: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days. RESULTS: A total of 77 patients were included (median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th-75th percentile 12.0-21.0] vs. 3.5% [25th-75th percentile 0-11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7 (25th-75th percentile 5.5-19.1) in mild PVL and 17.7 (25th-75th percentile 3.6-19.4) in moderate PVL (p = 0.04). CONCLUSION: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies.

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.

Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: a state-of-the-art expert review.

Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy.

Automatic Detection of the Aortic Annular Plane and Coronary Ostia from Multidetector Computed Tomography.

Anatomic landmark detection is crucial during preoperative planning of transcatheter aortic valve implantation (TAVI) to select the proper device size and assess the risk of complications. The detection is currently a time-consuming manual process influenced by the image quality and subject to operator variability. In this work, we propose a novel automatic method to detect the relevant aortic landmarks from MDCT images using deep learning techniques. We trained three convolutional neural networks (CNNs) with 344 multidetector computed tomography (MDCT) acquisitions to detect five anatomical landmarks relevant for TAVI planning: the three basal attachment points of the aortic valve leaflets and the left and right coronary ostia. The detection strategy used these three CNN models to analyse a single MDCT image and yield three segmentation volumes as output. These segmentation volumes were averaged into one final segmentation volume, and the final predicted landmarks were obtained during a postprocessing step. Finally, we constructed the aortic annular plane, defined by the three predicted hinge points, and measured the distances from this plane to the predicted coronary ostia (i.e., coronary height). The methodology was validated on 100 patients. The automatic landmark detection was able to detect all the landmarks and showed high accuracy as the median distance between the ground truth and predictions is lower than the interobserver variations (1.5 mm [1.1-2.1], 2.0 mm [1.3-2.8] with a paired difference -0.5 ± 1.3 mm and p value <0.001). Furthermore, a high correlation is observed between predicted and manually measured coronary heights (for both R 2 = 0.8). The image analysis time per patient was below one second. The proposed method is accurate, fast, and reproducible. Embedding this tool based on deep learning in the preoperative planning routine may have an impact in the TAVI environments by reducing the time and cost and improving accuracy.

Enabling Automated Device Size Selection for Transcatheter Aortic Valve Implantation.

The number of transcatheter aortic valve implantation (TAVI) procedures is expected to increase significantly in the coming years. Improving efficiency will become essential for experienced operators performing large TAVI volumes, while new operators will require training and may benefit from accurate support. In this work, we present a fast deep learning method that can predict aortic annulus perimeter and area automatically from aortic annular plane images. We propose a method combining two deep convolutional neural networks followed by a postprocessing step. The models were trained with 355 patients using modern deep learning techniques, and the method was evaluated on another 118 patients. The method was validated against an interoperator variability study of the same 118 patients. The differences between the manually obtained aortic annulus measurements and the automatic predictions were similar to the differences between two independent observers (paired diff. of 3.3 ± 16.8 mm2 vs. 1.3 ± 21.1 mm2 for the area and a paired diff. of 0.6 ± 1.7 mm vs. 0.2 ± 2.5 mm for the perimeter). The area and perimeter were used to retrieve the suggested prosthesis sizes for the Edwards Sapien 3 and the Medtronic Evolut device retrospectively. The automatically obtained device size selections accorded well with the device sizes selected by operator 1. The total analysis time from aortic annular plane to prosthesis size was below one second. This study showed that automated TAVI device size selection using the proposed method is fast, accurate, and reproducible. Comparison with the interobserver variability has shown the reliability of the strategy, and embedding this tool based on deep learning in the preoperative planning routine has the potential to increase the efficiency while ensuring accuracy.

Learning from failure in healthcare: Dynamic panel evidence of a physician shock effect.

Procedural failures of physicians or teams in interventional healthcare may positively or negatively predict subsequent patient outcomes. We identify this effect by applying (non)linear dynamic panel methods to data from the Belgian transcatheter aorta valve implantation registry containing information on the first 860 transcatheter aorta valve implantation procedures in Belgium. We find that a previous death of a patient positively and significantly predicts subsequent survival of the succeeding patient. We find that these learning from failure effects are not long-lived and that learning from failure is transmitted across adverse events.

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

AIMS: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. METHODS AND RESULTS: Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days. CONCLUSION: Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.

A higher volume of fibrotic tissue on virtual histology prior to coronary stent implantation predisposes to more pronounced neointima proliferation.

BACKGROUND: Since neointima smooth muscle cells (SMC) mainly originate from the vessel wall, we investigated whether atherosclerotic plaque composition influences subsequent in-stent neointima proliferation and restenosis. METHODS: We performed intravascular ultrasound (IVUS) with virtual histology in 98 patients prior to elective bare-metal stent (BMS) implantation in de novo coronary artery lesions. Virtual histology variables pre-percutaneous coronary intervention (PCI) were related to in-stent neointima proliferation six months after implantation assessed as late luminal loss of 0.88 mm (interquartile range (IQR) 0.37-1.23 mm) on angiography and as maximal percentage area stenosis of 42% (IQR 33-59%) and percentage volume intima hyperplasia of 27% (IQR 20-36%) on IVUS. A ridge-trace based multiple linear regression model was constructed to account for multicollinearity of the virtual histology variables and was corrected for implanted stent length (18 mm, IQR 15-23 mm), stent diameter (3.0 mm, IQR 2.75-3.5 mm) and lesion volume (146 mm³, IQR 80-201 mm³) prior to PCI. RESULTS: Fibrous tissue volume prior to PCI (49 mm³, IQR 30-77 mm³) was significantly and independently related to late luminal loss (p = .038), maximal percentage area stenosis (p = .041) and percentage volume intima hyperplasia (p = .004). Neither absolute nor relative amounts of fibrofatty, calcified or necrotic core tissue appeared related to any of the restenosis parameters. Subgroup analysis after exclusion of acute coronary syndrome (ACS) patients yielded similar results. CONCLUSION: Lesions with more voluminous fibrotic tissue pre-PCI show more pronounced in-stent neointima proliferation, even after correction for lesion plaque volume.

Comparison of radial access versus femoral access with the use of a vascular closure device for the prevention of vascular complications and mortality after percutaneous coronary intervention.

BACKGROUND: Radial access (RA) and vascular closure devices (VCD) have been shown to be superior to transfemoral access (TFA) with regard to the prevention of vascular complications after percutaneous coronary intervention (PCI). OBJECTIVE: The present study evaluates whether RA is associated with less vascular complications and a lower mortality than VCD. METHODS: A total of 6999 consecutive PCI patients were studied through a single-centre prospective registry from January 2011 to August 2015. RA was applied in 1385 patients (20%), VCDs with Angio-Seal were implanted in 2145 patients (30%) and manual compression of TFA was performed in 3468 patients (50%). RESULTS: RA and VCD patients had comparable baseline risk profiles. The overall vascular complication rate was 2.0% (n = 137) and was composed of false aneurysms (n = 85), clinically relevant haematomas (n = 27), arteriovenous fistulas (n = 12), arterial occlusions (n = 11) and local infections (n = 2). Vascular complications occurred in 0.6% of RA patients, 1.8% of VCD patients and 2.6% of TFA patients (p < .01). In-hospital mortality was 0.8% in RA patients, 0.8% in VCD patients and 3.8% in TFA patients (p < .01). In a multivariate logistic regression model, RA, compared to VCD, was found to be independently associated with a lower rate of vascular complications (OR: 0.34, 95% CI: 0.16-0.75), but not with lower mortality rates (OR: 1.20, 95% CI: 0.51-2.85). CONCLUSION: In this large all-comers PCI population, the radial approach, compared to the femoral approach with VCD use (Angio-Seal), was independently associated with a reduction of vascular complications, but not with lower mortality rates.

Does my high blood pressure improve your survival? Overall and subgroup learning curves in health.

Learning curves in health are of interest for a wide range of medical disciplines, healthcare providers, and policy makers. In this paper, we distinguish between three types of learning when identifying overall learning curves: economies of scale, learning from cumulative experience, and human capital depreciation. In addition, we approach the question of how treating more patients with specific characteristics predicts provider performance. To soften collinearity problems, we explore the use of least absolute shrinkage and selection operator regression as a variable selection method and Theil-Goldberger mixed estimation to augment the available information. We use data from the Belgian Transcatheter Aorta Valve Implantation (TAVI) registry, containing information on the first 860 TAVI procedures in Belgium. We find that treating an additional TAVI patient is associated with an increase in the probability of 2-year survival by about 0.16%-points. For adverse events like renal failure and stroke, we find that an extra day between procedures is associated with an increase in the probability for these events by 0.12%-points and 0.07%-points, respectively. Furthermore, we find evidence for positive learning effects from physicians' experience with defibrillation, treating patients with hypertension, and the use of certain types of replacement valves during the TAVI procedure.

Morphological Characteristics and Calcification of the Native Aortic Valve and the Relation to Significant Aortic Regurgitation after CoreValve TAVI.

BACKGROUND AND AIM OF THE STUDY: Aortic regurgitation (AR) is a frequent and life-limiting complication after transcatheter aortic valve implantation (TAVI). The study aim was to relate post-TAVI AR, using a self-expandable stent, to detailed baseline anatomical and morphological characteristics of the native aortic valve. METHODS: A total of 82 patients (40 males, 42 females; mean age 80 ± 7 years) who received a Medtronic CoreValve implant was included. Aortic root morphology, aortic annulus and implant size mismatch, implant position, extent of aortic annulus and leaflet calcification, the connected sub-annular calcification volume, and their distribution were quantified based on computed tomography scan analysis. AR following TAVI was quantified using standardized angiography and echocardiography. RESULTS: The mean logistic EuroSCORE of all patients was 16.9 ± 11.1%. According to angiography and echocardiography, 41% and 39% respectively, of the patients had AR grade ≥2. The two methods correlated moderately (Spearman's ρ = 0.51, p <0.001). The maximal diameter of the native annulus was larger in patients with significant AR after TAVI based on echocardiography (28.0 mm versus 26.8 mm, p = 0.059). Excessive calcification, especially on the left coronary cusp, was present in patients with significant AR, based on angiography (AR ≥II 71.0 mm3 versus AR

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.

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.

Preprocedural CT evaluation of transcatheter aortic valve replacement: what the radiologist needs to know.

Aortic valve stenosis is the most common valvular heart disease in the Western world. When symptomatic, aortic valve stenosis is a debilitating disease with a dismal short-term prognosis, invariably leading to heart failure and death. Elective surgical valve replacement has traditionally been considered the standard of care for symptomatic aortic valve stenosis. However, several studies have identified various subgroups of patients with a significantly elevated risk for surgery-related complications and death. Thus, not every patient is a suitable candidate for surgery. Recent developments in transcatheter-based therapies have provided an alternative therapeutic strategy for the nonsurgical patient population known as transcatheter aortic valve replacement (TAVR) (also called transcatheter aortic valve implantation or percutaneous aortic valve replacement). In TAVR, the native aortic valve is replaced with a bioprosthetic valve via a nonsurgical endovascular, transaortic, or transapical pathway. Nevertheless, several anatomic and technical criteria must be met to safeguard patient eligibility and procedural success. Therefore, noninvasive imaging plays a crucial role in both patient selection and subsequent matching to a specific transcatheter valve size in an effort to ensure accurate prosthesis deployment and minimize peri- and postprocedural complications. The authors review the relevant anatomy of the aortic root, emphasizing the implications of anatomic pitfalls for correct reporting of imaging-derived measurements and important differences between findings obtained with different imaging modalities. They also discuss the evolving role of computed tomography and the role of the radiologist in patient triage in light of current viewpoints regarding patient selection, device size selection, and the preprocedural evaluation of possible access routes. Online supplemental material is available for this article.

Transcatheter aortic valve replacement: postoperative CT findings of Sapien and CoreValve transcatheter heart valves.

Transcatheter aortic valve replacement represents one of the most exciting medical technical developments in recent years, offering a much-needed therapeutic alternative for patients with severe aortic valve stenosis who, due to comorbidities and advanced age, are considered to be inoperable or at high surgical risk. The efficacy of this procedure compared with standard surgical intervention has been properly validated in multicenter randomized controlled trials (PARTNER A and B trials), leading to widespread clinical implementation, with over 50,000 procedures currently being performed worldwide each year. Although much of the attention has rightly focused on the potential role of computed tomography (CT) in the preprocedural assessment of the aortic root and the establishment of imaging-guided valve-sizing algorithms, less is known regarding the postprocedural CT characteristics of transcatheter heart valves (THVs). However, given the increasing worldwide recognition and clinical implementation of these devices, they will no doubt be encountered with increasing frequency in patients referred for thoracic CT, either for postprocedural evaluation of the aortic root or for unrelated reasons. Familiarity with these devices and their CT characteristics will increase diagnostic confidence and the value of the radiology report. The authors describe the physical and imaging properties of the currently commercially available THVs, their normal postprocedural imaging appearances, and potential complications that can be detected at CT. In addition, they discuss the relative strengths and weaknesses of CT and echocardiography in this setting.

Tumour necrosis factor-alpha serum level is an independent predictor of medium-term all-cause mortality after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a suitable treatment for patients with severe aortic stenosis and severely increased operative risk. There is need for a better preoperative risk assessment for TAVI candidates. AIM: To determine whether Tumour necrosis factor-alfa (TNFα) is an independent predictor of survival 500 days after TAVI. METHODS: Sixty patients undergoing TAVI were enrolled in the study. TNFα was determined. The CT measured low-density muscle fraction (LDM%) of the psoas muscle was determined. Operative risk assessment by Logistic EuroSCORE, EuroSCORE II, and STS score was performed. Frailty scores (FRAIL scale and Barthel index) were determined. RESULTS: Mean age was 81.01 ± 7.54 years. Twenty-six (43.3%) of the patients were males. In the univariable analyses, FRAIL scale and Barthel index were no predictors of survival after TAVI. In the multivariable analysis, including EuroSCORE II, LDM% and TNFα serum concentration, TNFα serum level was an independent predictor of survival 500 days after TAVI (HR: 3.167; 95%: 1.279-7.842; p = 0.013). The multivariable analysis, including TNFα as a categorical variable, showed that compared to patients in the conjugated first and second TNFα serum level tertile, patients in the third tertile had a hazard ratio (HR) of 10.606 (95%CI: 1.203 - 93.467) (p = 0.033). CONCLUSION: TNFα is an incremental independent predictor of long-term survival after TAVI.

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.

Resolute and Xience V polymer-based drug-eluting stents compared in an atherosclerotic rabbit double injury model.

AIM: To evaluate differences in strut coverage, inflammation and endothelialization between two second-generation polymer-based drug-eluting stents (DES) in an atherosclerotic rabbit double-injury iliac artery model at 28 days follow-up. METHODS AND RESULTS: Rabbits with induced atheroma received bilateral iliac artery stents: everolimus-eluting stent (Xience V EES; Abbott Vascular), zotarolimus-eluting stent (Resolute ZES; Medtronic CardioVascular), or bare-metal stent (BMS; MultiLink Vision; Abbott Vascular). After 28 days, total neointimal coverage examined by scanning electron microscopy was >98% for all three stent types. Neointimal thickness above stent struts was decreased by 50% in Xience V EES (0.06 ± 0.01 mm; P = 0.00001) compared with BMS (0.15 ± 0.03 mm) and Resolute ZES (0.12 ± 0.04 mm). Luminal area was largest for Xience V EES (3.79 ± 0.33 mm(2) ; P = 0.0003 for Xience V EES vs. BMS), followed by Resolute ZES (3.46 ± 0.45 mm(2) ; P = 0.083 for Resolute ZES vs. BMS) and BMS (3.07 ± 0.53 mm(2) ). Percentage area stenosis was smallest for Xience V EES (17.23 ± 3.64%; P = 0.00001), while BMS (30.25 ± 7.48%) and Resolute ZES (30.79 ± 7.15%) did not differ. Endothelial monolayer regrowth was significantly lower in Resolute ZES (65 ± 13%) versus BMS (79 ± 11%; P = 0.004). There was no difference between Xience V EES (74 ± 10%) and BMS. Xience V EES was further associated with a lower number of inflammatory cells surrounding the stent struts (7 ± 2 per strut) in comparison to Resolute ZES (15 ± 6; P = 0.0001) and BMS (17 ± 9; P = 0.0005). CONCLUSION: In this atherosclerotic rabbit model, Xience V EES suppressed neointimal thickening better, with normal endothelial regrowth as compared with BMS, and less strut-induced inflammation.

Hospitalization costs ofTAVI in one Belgian university hospital.

OBJECTIVE: Considering the sizeable cost of transcatheter aortic valve implantation (TAVI) and conflicting cost-effectiveness studies, it is useful to gain more insight into the cost structure of the TAVI hospitalization. This study provides such a cost analysis and starts to evaluate options to soften the hospitalization cost burden in order to make TAVI economically more feasible. METHODS: Costs forTAVI hospitalization in the University Hospital of Antwerp were analysed uni- and bivariately. Graphical and numerical displays of the data are supplemented with the non-parametric Wilcoxon rank sum statistic and Spearman rank rho correlation. RESULTS: Overall, 47 percent of the cost could be attributed to the implanted valve and 21 percent was accounted for by the room costs. Further, costs seemed highly insensitive to pre-existing patient characteristics. Only patients with pulmonary hypertension were characterized with systematically higher costs (Wilcoxon rank sum P-value of 0.049). Complications related to TAVI had a significant upward impact on the costs and there was also evidence for a learning effect on total costs. CONCLUSIONS: In general the analyses showed that only limited options remain for cost reduction of the TAVI hospitalization cost. The most promising option is the reduction of the valve price. Avoidance of complications is hard to achieve given the current state of the art although this would significantly reduce overall costs.

Computed tomography measured epicardial adipose tissue and psoas muscle attenuation: new biomarkers to predict major adverse cardiac events and mortality in patients with heart disease and critically ill patients. Part II: Psoas muscle area and density.

Sarcopenia is a syndrome characterised by loss of skeletal muscle mass, loss of muscle quality, and reduced muscle strength, resulting in low performance. Sarcopenia has been associated with increased mortality and complications after medical interventions. In daily clinical practice, sarcopenia is assessed by clinical assessment of muscle strength and performance tests and muscle mass quantification by dual-energy X-ray absorptio-metry (DXA) or bioelectrical impedance analysis (BIA). Assessment of the skeletal muscle quantity and quality obtained by abdominal computed tomography (CT) has gained interest in the medical community, as abdominal CT is performed for various medical reasons, and quantification of the psoas and skeletal muscle can be performed without additional radiation load and dye administration. The definitions of CT-derived skeletal muscle mass quantification are briefly reviewed: psoas muscle area (PMA), skeletal muscle area (SMA), and transverse psoas muscle thickness (TPMT). We explain how CT attenuation coefficient filters are used to determine PMA and SMA, resulting in the psoas muscle index (PMI) and skeletal muscle index (SMI), respectively, after indexation to body habitus. Psoas muscle density (PMD), a biomarker for skeletal muscle quality, can be assessed by measuring the psoas muscle CT attenuation coefficient, expressed in Hounsfield units. The concept of low-density muscle (LDM) is explained. Finally, we review the medical literature on PMI and PMD as predictors of adverse outcomes in patients undergoing trauma or elective major surgery, transplantation, and in patients with cardiovascular and internal disease. PMI and PMD are promising new biomarkers predicting adverse outcomes after medical interventions.