Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands

Netherlands Heart Journal - We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve...     

Determinants of elevated carbohydrate antigen 125 in patients with severe symptomatic aortic valve stenosis referred for transcatheter aortic valve implantation

Purpose: Elevated carbohydrate antigen 125 (CA125) predicts adverse outcome after transcatheter aortic valve implantation (TAVI). While known underlying pathophysiological mechanisms of elevated CA125 include serosal effusions and inflammatory stimuli, clinical determinants associated with elevated CA125 in patients referred for TAVI remain unknown. Therefore, we investigated clinical, laboratory and echocardiographic determinants of elevated CA125 in patients with severe aortic valve stenosis referred for TAVI.

Methods: This study includes 650 patients with severe aortic stenosis referred for TAVI. Baseline CA125 was determined by an immunoassay and dichotomized (elevated versus normal) based on the manufacturer cutoff value (>35?U/mL).

Results: CA125 elevation was present in 28% (181/650). Patients with elevated CA125 had an overall worse clinical profile and were more symptomatic with a higher rate of NYHA class III/IV (80% versus 58%; p?Conclusion: Elevated CA125 levels in patients referred for TAVI summarize a subset of patients with an overall worse clinical profile who are more symptomatic.     

Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices

Objective

Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome.

Methods

We enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year.

Results

PPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p?=?0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p?=?0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p?=?0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p?=?0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50–1.74, p?=?0.83).

Conclusions

In this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.

     

Simulation of transcatheter aortic valve implantation through patient-specific finite element analysis: Two clinical cases

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure introduced to treat aortic valve stenosis in elder patients. Its clinical outcomes are strictly related to patient selection, operator skills, and dedicated pre-procedural planning based on accurate medical imaging analysis. The goal of this work is to define a finite element framework to realistically reproduce TAVI and evaluate the impact of aortic root anatomy on procedure outcomes starting from two real patient datasets. Patient-specific aortic root models including native leaflets, calcific plaques extracted from medical images, and an accurate stent geometry based on micro-tomography reconstruction are key aspects included in the present study. Through the proposed simulation strategy we observe that, in both patients, stent apposition significantly induces anatomical configuration changes, while it leads to different stress distributions on the aortic wall. Moreover, for one patient, a possible risk of paravalvular leakage has been found while an asymmetric coaptation occurs in both investigated cases. Post-operative clinical data, that have been analyzed to prove reliability of the performed simulations, show a good agreement with analysis results. The proposed work thus represents a further step towards the use of realistic computer-based simulations of TAVI procedures, aiming at improving the efficacy of the operation technique and supporting device optimization.     

Incidence and outcome of prosthetic valve endocarditis after transcatheter aortic valve replacement in the Netherlands

Background

Transcatheter aortic valve replacement (TAVR) is increasingly being used as an alternative to conventional surgical valve replacement. Prosthetic valve endocarditis (PVE) is a rare but feared complication after TAVR, with reported first-year incidences varying from 0.57 to 3.1%. This study was performed to gain insight into the incidence and outcome of PVE after TAVR in the Netherlands.

Methods

A multicentre retrospective registry study was performed. All patients who underwent TAVR in the period 2010–2017 were screened for the diagnosis of infective endocarditis in the insurance database and checked for the presence of PVE before analysis of general characteristics, PVE parameters and outcome.

Results

A total of 3968 patients who underwent TAVR were screened for PVE. During a median follow-up of 33.5 months (interquartile range (IQR) 22.8–45.8), 16 patients suffered from PVE (0.4%), with a median time to onset of 177 days (IQR 67.8–721.3). First-year incidence was 0.24%, and the overall incidence rate was 0.14 events per 1000 person-years. Overall mortality during follow-up in our study was 31%, of which 25% occurred in hospital. All patients were treated conservatively with intravenous antibiotics alone, and none underwent a re-intervention. Other complications of PVE occurred in 5 patients (31%) and included aortic abscess (2), decompensated heart failure (2) and cerebral embolisation (1).

Conclusion

PVE in patients receiving TAVR is a relatively rare complication and has a high mortality rate.

     

Echocardiographic evaluation of delayed outcome of artificial valve implantation in patients with aortic semilunar valve insufficiency]

An average follow-up period of 16 patients was 28 months following an implantation of the artificial aortic valve for its insufficiency. In 10 operated patients who were able to continue their occupation exercise tolerance increased by two classes, according to NYHA. Blood pressure gradient decreased significantly from 61.8 to 37.5 mmHg, cardiac volume index decreased from 639 to 602 ml/m2. Echocardiographically measured muscle mass of the left ventricle, end-diastolic and end-systolic volumes, and the left atrial dimensions decreased significantly following surgery. A significance of the relation of the left ventricle volume to its mass <4 as a prognostic factor in aortic valve replacement has also been confirmed.     

Simulation of transcatheter aortic valve implantation: a patient-specific finite element approach

Until recently, heart valve failure has been treated adopting open-heart surgical techniques and cardiopulmonary bypass. However, over the last decade, minimally invasive procedures have been developed to avoid high risks associated with conventional open-chest valve replacement techniques. Such a recent and innovative procedure represents an optimal field for conducting investigations through virtual computer-based simulations: in fact, nowadays, computational engineering is widely used to unravel many problems in the biomedical field of cardiovascular mechanics and specifically, minimally invasive procedures. In this study, we investigate a balloon-expandable valve and we propose a novel simulation strategy to reproduce its implantation using computational tools. Focusing on the Edwards SAPIEN valve in particular, we simulate both stent crimping and deployment through balloon inflation. The developed procedure enabled us to obtain the entire prosthetic device virtually implanted in a patient-specific aortic root created by processing medical images; hence, it allows evaluation of postoperative prosthesis performance depending on different factors (e.g. device size and prosthesis placement site). Notably, prosthesis positioning in two different cases (distal and proximal) has been examined in terms of coaptation area, average stress on valve leaflets as well as impact on the aortic root wall. The coaptation area is significantly affected by the positioning strategy ( ? 24%, moving from the proximal to distal) as well as the stress distribution on both the leaflets (+13.5%, from proximal to distal) and the aortic wall ( ? 22%, from proximal to distal). No remarkable variations of the stress state on the stent struts have been obtained in the two investigated cases.     

Postoperative analysis of the mechanical interaction between stent and host tissue in patients after transcatheter aortic valve implantation

The analysis is based on a finite element procedure to extract the contact forces between an implanted Nitinol stent and the surrounding host tissue using postoperative CT images. The methodology was applied for patients (N=46) which have undergone a TAVI procedure with the Medtronic CoreValve Revalving System (MCRS) to obtain corresponding deformation and force maps. The postoperative CT data were recorded for each patient in both systolic and diastolic phase of the heart cycle. Scalar parameters were defined, which map deformed geometry and contact force field to mechanically relevant quantities: radial dilatation, radial shape distortion, non-convex points, mean force, a force deviation measure and a pressure equivalent. The latter demonstrates that in the area of the aortic root, the added circumferential loading is of the same order as the baseline average blood pressure, thus leading to a doubling of the local mechanical load. Generally the force distribution along the stent is non-homogeneous. A comparison of systolic and diastolic data revealed slightly higher contact forces during the diastole, indicating that the stent has to carry more load in this phase. The geometrical and mechanical parameters were compared for two types of clinical complication: para-valvular leakage (PVL) and permanent pacemaker requirement (PPM). It was found that an increase in mean force can be associated with both complications; significantly for PVL and as a trend for PPM.     

Concomitant transapical transcatheter aortic valve implantation and minimally invasive direct coronary artery bypass

We represent a successful minimally invasive combined off-pump procedure consisting of a transapical aortic valve implantation and a direct coronary artery bypass grafting in a woman with a severe aortic stenosis and a critical coronary artery disease. Due to her comorbidities, she was classified as a high-risk patient qualifying for a transcatheter procedure. We performed this combined procedure in a hybrid operation room, starting with the coronary bypass to maintain a coronary blood flow during the transapical valve implantation. The operation processed without any complications and she was discharged at the seventh postoperative day into the allocating hospital.     

The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation

Aortic valve stenosis is one of the most common valvular abnormalities, which can manifest as angina, syncope, dyspnoea and sudden cardiac death. Transcath     

A new body shape index predicts mortality hazard independently of body mass index

Background

Obesity, typically quantified in terms of Body Mass Index (BMI) exceeding threshold values, is considered a leading cause of premature death worldwide. For given body size (BMI), it is recognized that risk is also affected by body shape, particularly as a marker of abdominal fat deposits. Waist circumference (WC) is used as a risk indicator supplementary to BMI, but the high correlation of WC with BMI makes it hard to isolate the added value of WC.

Methods and Findings

We considered a USA population sample of 14,105 non-pregnant adults () from the National Health and Nutrition Examination Survey (NHANES) 1999–2004 with follow-up for mortality averaging 5 yr (828 deaths). We developed A Body Shape Index (ABSI) based on WC adjusted for height and weight: ABSI had little correlation with height, weight, or BMI. Death rates increased approximately exponentially with above average baseline ABSI (overall regression coefficient of per standard deviation of ABSI [95% confidence interval: –]), whereas elevated death rates were found for both high and low values of BMI and WC. (–) of the population mortality hazard was attributable to high ABSI, compared to (–) for BMI and (–) for WC. The association of death rate with ABSI held even when adjusted for other known risk factors including smoking, diabetes, blood pressure, and serum cholesterol. ABSI correlation with mortality hazard held across the range of age, sex, and BMI, and for both white and black ethnicities (but not for Mexican ethnicity), and was not weakened by excluding deaths from the first 3 yr of follow-up.

Conclusions

Body shape, as measured by ABSI, appears to be a substantial risk factor for premature mortality in the general population derivable from basic clinical measurements. ABSI expresses the excess risk from high WC in a convenient form that is complementary to BMI and to other known risk factors.     

Prevalence of blood type A and risk of vascular complications following transcatheter aortic valve implantation

Objectives

To assess the prevalence of blood type A among patients referred for transcatheter aortic valve implantation (TAVI) and whether it is related to vascular complications.

Backgrounds

Vascular complications following TAVI are associated with adverse outcomes. Various blood types, particularly type A, have been shown to be more prevalent in cardiovascular diseases and to be related to prognosis.

Methods

The prevalence of various blood types in a cohort of 491 consecutive patients who underwent TAVI was compared with a control group of 6500 consecutive hospitalised patients. The prevalence and predictors of vascular complications and bleeding events were evaluated in the blood type A group and were compared with non-type A patients.

Results

The mean age of TAVI patients was 83?±?6 years, and 40?% were males. Patients were divided into two groups: blood type A (n?=?220) and non-type A (n?=?271). Type A was significantly more prevalent in the TAVI group than in the control group (45 vs. 38?%, p?=?0.023). Compared with the non-type A group, patients with blood type A had more major and fatal bleeding (14.5 vs. 8.1?%, p?=?0.027) and more vascular complications (any vascular complication: 24.5 vs. 15.9?% p?=?0.016; major vascular complications: 12.3 vs. 7?% p?=?0.047). In a multivariable analysis, blood type A emerged as a significant and independent predictor for vascular complications and bleeding events.

Conclusions

Blood type A is significantly more prevalent in TAVI patients than in the general population and is related to higher rates of vascular and bleeding complications.

     

Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial

Netherlands Heart Journal - Immobilisation of patients after transfemoral transcatheter aortic valve implantation (TF-TAVI) is the standard of care, mostly to prevent vascular complications....     

Patient-specific modeling of biomechanical interaction in transcatheter aortic valve deployment

The objective of this study was to develop a patient-specific computational model to quantify the biomechanical interaction between the transcatheter aortic valve (TAV) stent and the stenotic aortic valve during TAV intervention. Finite element models of a patient-specific stenotic aortic valve were reconstructed from multi-slice computed tomography (MSCT) scans, and TAV stent deployment into the aortic root was simulated. Three initial aortic root geometries of this patient were analyzed: (a) aortic root geometry directly reconstructed from MSCT scans, (b) aortic root geometry at the rapid right ventricle pacing phase, and (c) aortic root geometry with surrounding myocardial tissue. The simulation results demonstrated that stress, strain, and contact forces of the aortic root model directly reconstructed from MSCT scans were significantly lower than those of the model at the rapid ventricular pacing phase. Moreover, the presence of surrounding myocardium slightly increased the mechanical responses. Peak stresses and strains were observed around the calcified regions in the leaflets, suggesting the calcified leaflets helped secure the stent in position. In addition, these elevated stresses induced during TAV stent deployment indicated a possibility of tissue tearing and breakdown of calcium deposits, which might lead to an increased risk of stroke. The potential of paravalvular leak and occlusion of coronary ostia can be evaluated from simulated post-deployment aortic root geometries. The developed computational models could be a valuable tool for pre-operative planning of TAV intervention and facilitate next generation TAV device design.     

Genomic and proteomic determinants of outcome in patients undergoing thoracoabdominal aortic aneurysm repair

Thoracoabdominal aortic aneurysm repair, with its requisite intraoperative mesenteric ischemia-reperfusion, often results in the development of systemic inflammatory response syndrome, multiorgan dysfunction syndrome (MODS), and death. In the present study, an adverse clinical outcome following thoracoabdominal aortic aneurysm repair was identified by blood leukocyte genomic and plasma proteomic responses. Time-dependent changes in the expression of 146 genes from blood leukocytes were observed (p < 0.001). Expression of 138 genes (p < 0.001) and the concentration of seven plasma proteins discriminated between patients who developed MODS and those who did not, and many of these differences were evident even before surgery. These findings suggest that changes in blood leukocyte gene expression and plasma protein concentrations can illuminate pathophysiological processes that are subsequently associated with the clinical sequelae of systemic inflammatory response syndrome and MODS. These changes in gene expression and plasma protein concentrations are often observed before surgery, consistent with either a genetic predisposition or pre-existing inflammatory state.     

Association of elevated body mass index and hypertension with mortality: the CroHort study

Aim of this study was to investigate association of elevated body mass index and hypertension with general mortality in the cohort from Croatian Adult Health Cohort Study (CroHort). Risk of death according to body mass index (BMI) and blood pressure category, in period 2003/08, was calculated for 7,490 respondents, out of which 6,682 were alive and 808 were dead in 2008. Among men aged 65 and more, elevated BMI was associated with lower risk of death, in accordance with obesity paradox recorded in some previous studies which showed that older men with higher BMI have lower risk of death. Among women aged 50-64 years, being hypertensive was associated with increased risk of death compared to normotensive respondents. Despite obesity paradox which should be further explored, activities on primary and secondary prevention of excess weight and hypertension should be encouraged as means to prevent premature mortality in Croatian population.     

The estimation of body mass index and physical attractiveness is dependent on the observer's own body mass index

A disturbance in the evaluation of personal body mass and shape is a key feature of both anorexia and bulimia nervosa. However, it is uncertain whether overestimation is a causal factor in the development of these eating disorders or is merely a secondary effect of having a low body mass. Moreover, does this overestimation extend to the perception of other people''s bodies? Since body mass is an important factor in the perception of physical attractiveness, we wanted to determine whether this putative overestimation of self body mass extended to include the perceived attractiveness of others. We asked 204 female observers (31 anorexic, 30 bulimic and 143 control) to estimate the body mass and rate the attractiveness of a set of 25 photographic images showing people of varying body mass index (BMI). BMI is a measure of weight scaled for height (kg m(- 2)). The observers also estimated their own BMI. Anorexic and bulimic observers systematically overestimated the body mass of both their own and other people''s bodies, relative to controls, and they rated a significantly lower body mass to be optimally attractive. When the degree of overestimation is plotted against the BMI of the observer there is a strong correlation. Taken across all our observers, as the BMI of the observer declines, the overestimation of body mass increases. One possible explanation for this result is that the overestimation is a secondary effect caused by weight loss. Moreover, if the degree of body mass overestimation is taken into account, then there are no significant differences in the perceptions of attractiveness between anorexic and bulimic observers and control observers. Our results suggest a significant perceptual overestimation of BMI that is based on the observer''s own BMI and not correlated with cognitive factors, and suggests that this overestimation in eating-disordered patients must be addressed directly in treatment regimes.