Publications by authors named "Johan Bosmans"

117 Publications

Computed tomography measured psoas muscle attenuation predicts mortality after transcatheter aortic valve implantation.

J Cardiovasc Med (Hagerstown) 2021 Aug 12. Epub 2021 Aug 12.

Department of Cardiology, University Hospital Antwerp, Antwerp -Edegem, Belgium Department of Cardiology, ZorgSaam Hospital, Terneuzen, The Netherlands Faculty of Health Siences and Medicin Faculty of Biomedical Sciences, University of Antwerp, Campus Drie Eiken Universiteitsplein 1, Wilrijk Department of Cardiac Surgery, University Hospital Antwerp, Antwerp -Edegem, Belgium.

Purpose: Transcatheter aortic valve implantation (TAVI) is an appropriate treatment for severe symptomatic aortic stenosis in patients with a high operative risk.

Aims: The aim of this study was to determine if computed tomography (CT) psoas muscular attenuation measurements may predict all-cause mortality in patients undergoing TAVI.

Methods: Ninety-four consecutive patients undergoing TAVI were analysed. The CT axial slice at the level of the fourth lumbar vertebra was selected. The psoas muscle areas were manually contoured. The circumferential surface area (CSA) of both psoas muscles was determined by selecting the voxels with attenuation values, ranging from 0 to 100 Hounsfield Units (HU). The mean CT attenuation coefficient of the psoas muscle (Psoas mean HU) was measured. The muscle was subdivided into a low-density muscle (LDM) (0-29 HU) and high-density muscle (HDM) (30-100 HU) portion. The HDM/LDM ratio was calculated. We searched for a correlation between HDM/LDM, CSA LDM (%), Psoas mean HU and all-cause mortality.

Results: The mean age was 81.2 ± 7.5 years. Thirty patients had adverse outcome (all-cause mortality). Compared with patients with the lowest CSA LDM (%), patients in the third and second tertiles had an increased hazard ratio for mortality (2.871; 95% confidence interval 0.880-9.371 and 5.044; 95% confidence interval 1.641-15.795, respectively) in a multivariable model with EuroSCORE II, Barthel frailty index and CSA LDM (%) (P = 0.231, 0.097 and 0.019, respectively). HDM/LDM and Psoas mean HU (as continuous variable) were also independent predictors of all-cause mortality (P = 0.019, P = 0.013, respectively).

Conclusion: CSA LDM (%), Psoas mean HU and HDM/LDM are independent and incremental predictors of all-cause mortality in patients undergoing TAVI.
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http://dx.doi.org/10.2459/JCM.0000000000001234DOI Listing
August 2021

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.

Catheter Cardiovasc Interv 2021 Jul 31. Epub 2021 Jul 31.

Department of Medicine, University of Bonn, Bonn, Germany.

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.
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http://dx.doi.org/10.1002/ccd.29889DOI Listing
July 2021

Effect of Statin Therapy on the Carboxypeptidase U (CPU, TAFIa, CPB2) System in Patients With Hyperlipidemia: A Proof-of-concept Observational Study.

Clin Ther 2021 05 25;43(5):908-916. Epub 2021 Apr 25.

Laboratory of Medical Biochemistry, Department of Pharmaceutical Sciences, University of Antwerp, Antwerp, Belgium. Electronic address:

Purpose: Statins are commonly used in patients with hypercholesterolemia to lower their cholesterol levels and to reduce their cardiovascular risk. There is also considerable evidence that statins possess a range of cholesterol-independent effects, including profibrinolytic properties. This pilot study aimed to explore the influence of statins on procarboxypeptidase U (proCPU) biology and to search for possible effects and associations that can be followed up in a larger study.

Methods: Blood was collected from 16 patients with hyperlipidemia, before and after 3 months of statin therapy (simvastatin 20 mg or atorvastatin 20 mg). Fifteen age-matched normolipemic persons served as control subjects. Lipid parameters and markers of inflammation and fibrinolysis (proCPU levels and clot lysis times) were determined in all samples.

Findings: Mean (SD) proCPU levels were significantly higher in patients with hypercholesterolemia compared to control subjects (1186 [189] U/L vs 1061 [60] U/L). Treatment of these patients with a statin led to a significant average decrease of 11.6% in proCPU levels and brought the proCPU concentrations to the same level as in the control subjects. On a functional level, enhancement in plasma fibrinolytic potential was observed in the statin group, with the largest improvement in fibrinolysis seen in patients with the highest baseline proCPU levels and largest proCPU decrease upon statin treatment.

Implications: Increased proCPU levels are present in patients with hyperlipidemia. Statin treatment significantly decreased proCPU levels and improved plasma fibrinolysis in these patients. Moreover, our study indicates that patients with high baseline proCPU levels are most likely to benefit from statin therapy. The latter should be examined further in a large cohort.
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http://dx.doi.org/10.1016/j.clinthera.2021.03.011DOI Listing
May 2021

Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve.

JACC Cardiovasc Interv 2020 08 15;13(15):1803-1812. Epub 2020 Jul 15.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address:

Objectives: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice.

Background: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively.

Methods: A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation.

Results: Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13).

Conclusions: Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation.
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http://dx.doi.org/10.1016/j.jcin.2020.04.018DOI Listing
August 2020

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

J Interv Cardiol 2020 28;2020:9843275. Epub 2020 May 28.

Department of Electronics and Information Systems, UGent-imec, Technologiepark-Zwijnaarde 126, Ghent 9052, Belgium.

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 value <0.001). Furthermore, a high correlation is observed between predicted and manually measured coronary heights (for both  = 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.
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http://dx.doi.org/10.1155/2020/9843275DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275208PMC
November 2020

Enabling Automated Device Size Selection for Transcatheter Aortic Valve Implantation.

J Interv Cardiol 2019 3;2019:3591314. Epub 2019 Nov 3.

Department of Electronics and Information Systems, UGent-imec, Technologiepark-Zwijnaarde 126, Ghent, Belgium.

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 mm vs. 1.3 ± 21.1 mm 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.
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http://dx.doi.org/10.1155/2019/3591314DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875021PMC
April 2020

Differences in clinical valve size selection and valve size selection for patient-specific computer simulation in transcatheter aortic valve replacement (TAVR): a retrospective multicenter analysis.

Int J Cardiovasc Imaging 2020 Jan 12;36(1):123-129. Epub 2019 Sep 12.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.

Valve size selection for transcatheter aortic valve replacement (TAVR) is currently based on cardiac CT-scan. At variance with patient-specific computer simulation, this does not allow the assessment of the valve-host interaction. We aimed to compare clinical valve size selection and valve size selection by an independent expert for computer simulation. A multicenter retrospective analysis of valve size selection by the physician and the independent expert in 141 patients who underwent TAVR with the self-expanding CoreValve or Evolut R. Baseline CT-scan was used for clinical valve size selection and for patient-specific computer simulation. Simulation results were not available for clinical use. Overall true concordance between clinical and simulated valve size selection was observed in 47 patients (33%), true discordance in 15 (11%) and ambiguity in 79 (56%). In 62 (44%, cohort A) one valve size was simulated whereas two valve sizes were simulated in 79 (56%, cohort B). In cohort A, concordance was 76% and discordance was 24%; a smaller valve size was selected for simulation in 10 patients and a larger in 5. In cohort B, a different valve size was selected for simulation in all patients in addition to the valve size that was used for TAVR. The different valve size concerned a smaller valve in 45 patients (57%) and a larger in 34 (43%). Selection of the valve size differs between the physician and the independent computer simulation expert who used the same source of information. These findings indicate that valve sizing in TAVR is still more intricate than generally assumed.
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http://dx.doi.org/10.1007/s10554-019-01688-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942562PMC
January 2020

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

Eur Heart J 2020 05;41(20):1932-1940

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, Netherlands.

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.
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http://dx.doi.org/10.1093/eurheartj/ehz614DOI Listing
May 2020

Aortic root sizing for transcatheter aortic valve implantation using a shape model parameterisation.

Med Biol Eng Comput 2019 Oct;57(10):2081-2092

Faculty of Medicine and Health Sciences, Department of Translational Pathophysiological Research, Cardiovascular diseases, University of Antwerp, Universiteitsplein 1, 2610, Antwerp, Belgium.

During a transcatheter aortic valve implantation, an axisymmetric implant is placed in an irregularly shaped aortic root. Implanting an incorrect size can cause complications such as leakage of blood alongside or through the implant. The aim of this study was to construct a method that determines the optimal size of the implant based on the three-dimensional shape of the aortic root. Based on the pre-interventional computed tomography scan of 89 patients, a statistical shape model of their aortic root was constructed. The weights associated with the principal components and the volume of calcification in the aortic valve were used as parameters in a classification algorithm. The classification algorithm was trained using the patients with no or mild leakage after their intervention. Subsequently, the algorithms were applied to the patients with moderate to severe leakage. Cross validation showed that a random forest classifier assigned the same size in 65 ± 7% of the training cases, while 57 ± 8% of the patients with moderate to severe leakage were assigned a different size. This initial study showed that this semi-automatic method has the potential to correctly assign an implant size. Further research is required to assess whether the different size implants would improve the outcome of those patients.
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http://dx.doi.org/10.1007/s11517-019-01996-xDOI Listing
October 2019

Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis.

JACC Cardiovasc Interv 2019 01;12(1):78-86

Cardiology Department, University Hospital and National University of Ireland, Galway, Ireland.

Objectives: The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS).

Background: Oncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option.

Methods: A worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 "no-cancer" patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias.

Results: Cancer patients' age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients.

Conclusions: TAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997).
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http://dx.doi.org/10.1016/j.jcin.2018.10.026DOI Listing
January 2019

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.

JACC Cardiovasc Interv 2018 11;11(22):2326-2334

Department of Innovative Interventions in Cardiology, University of Bonn, Bonn, Germany.

Objectives: This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.

Background: The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.

Methods: This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.

Results: The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.

Conclusions: The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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http://dx.doi.org/10.1016/j.jcin.2018.07.032DOI Listing
November 2018

Rapid Ventricular Pacing for Neurovascular Surgery: A Study on Cardiac and Cerebral Effects.

World Neurosurg 2018 Nov 17;119:e71-e77. Epub 2018 Jul 17.

Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium; University of Antwerp, Antwerp, Belgium. Electronic address:

Background And Objective: Intraoperative rupture of a cerebral aneurysm during neurosurgery can be a devastating event that increases perioperative morbidity and mortality. Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. The objective of this study was to evaluate the neurological and cardiac effects of repetitive periods of RVP during cerebrovascular surgery.

Methods: Data from patients who underwent repetitive RVP during craniotomy for cerebrovascular disorders were retrospectively analyzed from a single-center medical records database (Cegeka Medical Health Care Systems). We compared preoperative and postoperative troponin levels (cTnI) to assess cardiac ischemia. Preoperative and postoperative magnetic resonance imaging (MRI) results were screened for RVP-induced infarcts by evaluating diffusion restriction in the hemisphere contralateral to the operated side and the fossa posterior.

Results: A total of 37 patients were analyzed. An immediate decrease of systolic arterial blood pressure (<60 mm Hg) was achieved after initiation of RVP. Postoperative MRI did not reveal areas of diffusion restriction. RVP tended to be a predictor of postoperative cTnI increase. Preoperative and postoperative cTnI levels were higher in patients with a subarachnoid hemorrhage compared to patients without one. After 24 hours cTnI jevels normalized to preoperative values.

Conclusions: Systolic arterial blood pressure decreased after RVP but normalized immediately when pacing stopped. MRI of the brain did not show RVP-related ischemia and the limited cTnI level increase normalized to preoperative values. Therefore, RVP during short periods of time seems to be a safe blood pressure-lowering technique for the brain and heart.
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http://dx.doi.org/10.1016/j.wneu.2018.07.002DOI Listing
November 2018

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

Health Econ 2018 May 2. Epub 2018 May 2.

Department of Cardiology, University of Antwerp, Antwerp, Belgium.

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.
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http://dx.doi.org/10.1002/hec.3668DOI Listing
May 2018

Patient-Specific Computer Simulation to Elucidate the Role of Contact Pressure in the Development of New Conduction Abnormalities After Catheter-Based Implantation of a Self-Expanding Aortic Valve.

Circ Cardiovasc Interv 2018 02;11(2):e005344

From the IBiTech-bioMMeda, Ghent University, Belgium (G.R., P.S., M.D.B.); Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands (N.E.F., P.d.J.); FEops NV, Ghent, Belgium (G.D.S., F.I., M.D.B., P.M.); University Hospital Antwerp, Belgium (J.B.); and Department of Cardiology, Rigshospitalet University Hospital, Copenhagen, Denmark (O.D.B., L.S.).

Background: The extent to which pressure generated by the valve on the aortic root plays a role in the genesis of conduction abnormalities after transcatheter aortic valve replacement (TAVR) is unknown. This study elucidates the role of contact pressure and contact pressure area in the development of conduction abnormalities after TAVR using patient-specific computer simulations.

Methods And Results: Finite-element computer simulations were performed to simulate TAVR of 112 patients who had undergone TAVR with the self-expanding CoreValve/Evolut R valve. On the basis of preoperative multi-slice computed tomography, a patient-specific region of the aortic root containing the atrioventricular conduction system was determined by identifying the membranous septum. Contact pressure and contact pressure index (percentage of area subjected to pressure) were quantified and compared in patients with and without new conduction abnormalities. Sixty-two patients (55%) developed a new left bundle branch block or a high-degree atrioventricular block after TAVR. Maximum contact pressure and contact pressure index (median [interquartile range]) were significantly higher in patients with compared with those without new conduction abnormalities (0.51 MPa [0.43-0.70 MPa] and 33% [22%-44%], respectively, versus 0.29 MPa [0.06-0.50 MPa] and 12% [1%-28%]). By multivariable regression analysis, only maximum contact pressure (odds ratio, 1.35; confidence interval, 1.1-1.7; =0.01) and contact pressure index (odds ratio, 1.52; confidence interval, 1.1-2.1; =0.01) were identified as independent predictors for conduction abnormalities, but not implantation depth.

Conclusions: Patient-specific computer simulations revealed that maximum contact pressure and contact pressure index are both associated with new conduction abnormalities after CoreValve/Evolut R implantation and can predict which patient will have conduction abnormalities.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.117.005344DOI Listing
February 2018

Predictors of 1-Year Mortality After Transcatheter Aortic Valve Implantation in Patients With and Without Advanced Chronic Kidney Disease.

Am J Cardiol 2017 Dec 4;120(11):2025-2030. Epub 2017 Sep 4.

Cardiology Department of the "Rabin Medical Center", Petah Tikva-Israel & "Sackler" school of medicine Tel Aviv University, Tel Aviv, Israel. Electronic address:

Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate ≤30 ml/min/1.73 m or permanent renal replacement therapy). Patients (n = 1204) from 10 centers in Europe, Japan, and Israel were included: 464 with and 740 without advanced CKD. Advanced CKD was associated with a 2-fold increase in the adjusted risk of 1-year all-cause death (p <0.001), and a 1.9-fold increase in cardiovascular death (p = 0.016). Interaction-term analysis was used to identify and compare independent predictors of 1-year mortality in both groups. Impaired left ventricular ejection fraction and poor functional class were predictive of death in the advanced CKD group (odds ratio [OR] 2.27, p = 0.002 and OR 3.87, p = 0.003, respectively) but not in patients without advanced CKD (p for interaction = 0.035 and 0.039, respectively), whereas bleeding was a predictor of mortality in the nonadvanced CKD group (OR 3.2, p = 0.005) but not in advanced CKD (p for interaction = 0.006). Atrial fibrillation was associated with a 2.2-fold increase (p = 0.032) in the risk of cardiovascular death in the advanced CKD group but not in the absence of advanced CKD (p for interaction = 0.022). In conclusion, the coexistence of advanced CKD and either reduced left ventricular ejection fraction or poor functional class has an incremental effect on the risk of death after TAVI. In contrast, bleeding had a greater effect on risk of death in patients without advanced CKD.
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http://dx.doi.org/10.1016/j.amjcard.2017.08.020DOI Listing
December 2017

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.

Acta Cardiol 2018 Jun 29;73(3):241-247. Epub 2017 Aug 29.

a Department of Cardiology , Antwerp University Hospital , Antwerp , Belgium.

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.
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http://dx.doi.org/10.1080/00015385.2017.1363947DOI Listing
June 2018

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

Acta Cardiol 2018 Apr 11;73(2):171-178. Epub 2017 Aug 11.

a The Department of Cardiology , Antwerp University Hospital , Edegem , Belgium.

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.
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http://dx.doi.org/10.1080/00015385.2017.1351258DOI Listing
April 2018

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study.

J Am Coll Cardiol 2017 Aug;70(7):845-853

Department of Cardiology, University Hospital Bern, Bern, Switzerland.

Background: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.

Objectives: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice.

Methods: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients.

Conclusions: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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http://dx.doi.org/10.1016/j.jacc.2017.06.045DOI Listing
August 2017

Transcatheter aortic valve implantation versus redo surgery for failing surgical aortic bioprostheses: a multicentre propensity score analysis.

EuroIntervention 2017 Nov;13(10):1149-1156

McGill University Health Centre, Montreal, Canada.

Aims: Transcatheter aortic valve implantation for a failing surgical bioprosthesis (TAV-in-SAV) has become an alternative for patients at high risk for redo surgical aortic valve replacement (redo-SAVR). Comparisons between these approaches are non-existent. This study aimed to compare clinical and echocardiographic outcomes of patients undergoing TAV-in-SAV versus redo-SAVR after accounting for baseline differences by propensity score matching.

Methods And Results: Patients from seven centres in Europe and Canada who had undergone either TAV-in-SAV (n=79) or redo-SAVR (n=126) were identified. Significant independent predictors used for propensity scoring were age, NYHA functional class, number of prior cardiac surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using a calliper range of ±0.05, a total of 78 well-matched patient pairs were found. All-cause mortality was similar between groups at 30 days (6.4% redo-SAVR vs. 3.9% TAV-in-SAV; p=0.49) and one year (13.1% redo-SAVR vs. 12.3% TAV-in-SAV; p=0.80). Both groups also showed similar incidences of stroke (0% redo-SAVR vs. 1.3% TAV-in-SAV; p=1.0) and new pacemaker implantation (10.3% redo-SAVR vs. 10.3% TAV-in-SAV; p=1.0). The incidence of acute kidney injury requiring dialysis was numerically lower in the TAV-in-SAV group (11.5% redo-SAVR vs. 3.8% TAV-in-SAV; p=0.13). The TAV-in-SAV group had a significantly shorter median total hospital stay (12 days redo-SAVR vs. 9 days TAV-in-SAV; p=0.001).

Conclusions: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and one-year clinical outcomes.
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http://dx.doi.org/10.4244/EIJ-D-16-00303DOI Listing
November 2017

Erratum to: Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study.

Clin Res Cardiol 2017 10;106(10):849

Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Leipzig, Germany.

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http://dx.doi.org/10.1007/s00392-017-1124-zDOI Listing
October 2017

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

Eur Heart J 2017 Sep;38(36):2729-2738

Department of Internal Medicine and Cardiology, University of Leipzig Heart Centre, Strümpellstraße 39, 04289 Leipzig, Germany.

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.
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http://dx.doi.org/10.1093/eurheartj/ehx295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5837353PMC
September 2017

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study.

JACC Cardiovasc Interv 2017 05;10(10):1048-1056

Rigshospitalet University Hospital, Copenhagen, Denmark.

Objectives: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR).

Background: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR.

Methods: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria.

Results: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively.

Conclusions: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.
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http://dx.doi.org/10.1016/j.jcin.2017.03.004DOI Listing
May 2017

Belgium: coronary and structural heart interventions from 2010 to 2015.

EuroIntervention 2017 May;13(Z):Z14-Z16

Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium, and Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.
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http://dx.doi.org/10.4244/EIJ-D-16-00825DOI Listing
May 2017

Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study.

Clin Res Cardiol 2017 Oct 8;106(10):784-795. Epub 2017 May 8.

Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Leipzig, Germany.

Background: Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting.

Objective: To report clinical and echocardiographic 3-year results from the ADVANCE study.

Methods: ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years.

Results: Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration.

Conclusions: Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality.

Trial Registration: ClinicalTrials.gov, NCT01074658.
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http://dx.doi.org/10.1007/s00392-017-1120-3DOI Listing
October 2017

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

Health Econ 2017 09 27;26(9):1094-1109. Epub 2017 Apr 27.

Department of Cardiology, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.

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.
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http://dx.doi.org/10.1002/hec.3505DOI Listing
September 2017

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

J Heart Valve Dis 2016 07;25(4):410-416

University of Antwerp, Department of Translational Pathophysiological Research, Cardiovascular Diseases, Faculty of Medicine and Health Sciences, Antwerp, Belgium.

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
Conclusions: Of the evaluated characteristics, a larger volume of calcification (especially on the left coronary cusp) is most related to the development of significant AR (grade II-IV) following implantation, when quantified by both angiography and echocardiography.
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July 2016

Relation Between Clinical Best Practices and 6-Month Outcomes After Transcatheter Aortic Valve Implantation With CoreValve (from the ADVANCE II Study).

Am J Cardiol 2017 Jan 30;119(1):84-90. Epub 2016 Sep 30.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

Best practices for transcatheter aortic valve implantation with CoreValve include patient screening and valve size selection using multislice computed tomography, adherence to manufacturer recommendations for oversizing, control of implant depth to 6 mm or less, and management of conduction disturbances according to international guidelines. The ADVANCE II study implemented these strategies and demonstrated their relation to clinical outcomes. From October 2011 to April 2013, 200 patients with severe aortic stenosis were enrolled, and 194 were implanted. All imaging and electrocardiographic data were analyzed by an independent core laboratory, and adverse events were adjudicated to valve academic research consortium-2 definitions. The mean age was 80.2 ± 6.7 years and the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 7.2 ± 6.8% for the enrolled patients. At 6 months, all-cause mortality was 9.2%, stroke was 2.6%, and permanent pacemaker implantation was 19.2% for class I and II indications. In patients with implant depth ≤6 mm, both mortality and permanent pacemaker implantation were lower than in patients with depth >6 mm (2.5% vs 14.5%, p <0.01 and 18.1% vs 31.7%, p = 0.03, respectively). The rate of moderate and severe paravalvular leak was 9.8% at 7 days after transcatheter aortic valve implantation, decreasing to 4.3% at 6 months (p = 0.02). Valves were significantly more oversized in patients with mild or less paravalvular leak at day 7 compared with those with moderate or severe (15.8 ± 8.0% vs 11.8 ± 4.9%, p = 0.01). In conclusion, findings from the ADVANCE II study reinforce that adherence to best clinical practices improves patient outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2016.09.016DOI Listing
January 2017

Impact of Renal Dysfunction on Results of Transcatheter Aortic Valve Replacement Outcomes in a Large Multicenter Cohort.

Am J Cardiol 2016 Dec 15;118(12):1888-1896. Epub 2016 Sep 15.

Cardiology Department, Rabin Medical Center, Petah Tikva, Israel; "Sackler" School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address:

Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients who underwent TAVR distinguished by renal function. Baseline characteristics, procedural data, and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel, and Japan. Data were analyzed according to renal function. Patients (n = 1,204) were divided into 4 groups according to pre-TAVR-estimated glomerular filtration rate (eGFR): group I (eGFR >60), n = 288 (female 45%), group II (eGFR 31 to 60), n = 452 (female 61%), group III (eGFR ≤30), n = 398 (female 61%), and group IV (dialysis), n = 66 (female 31%). Mean Society of Thoracic Surgeons score was higher in patients with lower preprocedural eGFR. All-cause mortality at 1 year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, and 24.2% for group I, II, III, and IV, respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31 to 60, was associated with increased risk of death (odds ratio 3), bleeding (odds ratio 5.2), and device implantation failure (hazard ratio 2.28). For each 10 ml/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p <0.001), cardiovascular death (14%; p = 0.018), major bleeding 35% (p <0.001), and transcatheter valve failure (16%; p = 0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion, among patients who underwent TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality.
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http://dx.doi.org/10.1016/j.amjcard.2016.08.082DOI Listing
December 2016

Transcatheter aortic valve replacement: a further step towards a patient-tailored therapy.

EuroIntervention 2016 Aug;12(6):695-7

Department of Cardiology, Interventional Cardiology, University Hospital Antwerp, Antwerp, Belgium.

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http://dx.doi.org/10.4244/EIJV12I6A112DOI Listing
August 2016

A validated methodology for patient specific computational modeling of self-expandable transcatheter aortic valve implantation.

J Biomech 2016 09 23;49(13):2824-2830. Epub 2016 Jun 23.

KULeuven, Department of Mechanical Engineering, Biomechanics Section, Faculty of Engineering Science, Celestijnenlaan 300C, 3001 Leuven, Belgium.

Leakage of blood alongside the implant is a relatively frequent and life-limiting complication after transcatheter aortic valve implantation. The aim of this study is to develop and validate a workflow to simulate the implantation prior to the intervention. Based on the simulation outcome, the amount of leakage is estimated in order to evaluate the risk of a severe complication. A finite element model of the stent implantation in 10 patients was created based on a pre-operative computed tomography scan. All 10 patients also received a follow-up computed tomography scan, after the implantation. This scan was used to extract the deformed geometry of the stent and the position of the calcifications for validation of the simulation results. The maximal average perimeter difference between the simulated stent and the post-operative stent is 2.9±2.1mm, and occurs at the bottom of the device. The sensitivity of the simulation to the soft tissue material parameters and aortic root wall thickness was tested. The maximal diameter deviation of 6% occurred when the thickness of the aortic root was doubled. The result of the leakage analysis based on the distance between the simulated stent and the surrounding aortic root corresponded well when no regurgitation was observed. The developed tools have the potential to reduce the occurrence and severity of leakage by providing the clinician with additional information prior to the intervention. The simulated geometry and estimated leakage can help decide on the best implant type, size and position before treatment.
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http://dx.doi.org/10.1016/j.jbiomech.2016.06.024DOI Listing
September 2016
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