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.

Adiponectin serum level is an independent and incremental predictor of all-cause mortality after transcatheter aortic valve replacement.

BACKGROUND: Quantifiable biomarkers may be useful for a better risk and frailty assessment of patients referred for transcatheter aortic valve implantation (TAVI). HYPOTHESIS: To determine if adiponectin serum concentration predicts all-cause mortality in patients undergoing TAVI. METHODS: 77 consecutive patients, undergoing TAVI, were analyzed. The CT axial slices at the level of the fourth lumbar vertebra were used to measure the psoas muscle area, and its low-density muscle fraction (LDM (%)). To assess the operative risk, the STS (Society of Thoracic Surgeons Predicted Risk of Mortality) score, Log. Euroscore, and Euroscore II were determined. A clinical frailty assessment was performed. ELISA kits were used to measure adiponectin serum levels. We searched for a correlation between serum adiponectin concentration and all-cause mortality after TAVI. RESULTS: The mean age was 80.8 ± 7.4 years. All-cause mortality occurred in 22 patients. The mean follow-up was 1779 days (range: 1572-1825 days). Compared with patients with the lowest adiponectin level, patients in the third tertile had a hazards ratio of all-cause mortality after TAVI of 4.155 (95% CI: 1.364-12.655) (p = .004). In the multivariable model, including STS score, vascular access of TAVI procedure, LDM (%), and adiponectin serum concentration, serum adiponectin level, and LDM(%) were independent predictors of all-cause mortality after TAVI (p = .178, .303, .042, and .017, respectively). Adiponectin level was a predictor of all-cause mortality in females and males (p = .012 and 0.024, respectively). CONCLUSION: Adiponectin serum level is an independent and incremental predictor of all-cause mortality in patients undergoing TAVI.

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

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 ±â€Š7.5 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.

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

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.

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

Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve.

AIMS: Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI. METHODS AND RESULTS: Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule. Bland-Altman analysis revealed a strong correlation between the observed (MSCT) and predicted frame dimensions, although small differences were detected for, e.g., Dmin at the inflow (mean±SD MSCT vs. MODEL: 21.6±2.4 mm vs. 22.0±2.4 mm; difference±SD: -0.4±1.3 mm, p<0.05) and Dmax (25.6±2.7 mm vs. 26.2±2.7 mm; difference±SD: -0.6±1.0 mm, p<0.01). The observed and predicted calcium displacements were highly correlated for the left and right coronary ostia (R2=0.67 and R2=0.71, respectively p<0.001). CONCLUSIONS: Dedicated software allows accurate prediction of frame morphology and calcium displacement after valve implantation, which may help to improve outcome.

Validation of transcatheter aortic valve implantation risk scores in relation to early and mid-term survival: a single-centre study.

OBJECTIVES: The aim of this study was to validate recently proposed risk scores for the prediction of mortality up to 1 year after transcatheter aortic valve implantation (TAVI), using a self-expandable valve (CoreValve). METHODS: In this single-centre study, 225 consecutive patients with severe symptomatic aortic valve stenosis, who underwent TAVI between December 2007 and January 2015, were included. Conventional surgical risk scores (logistic EuroSCORE, EuroSCORE II and STS score) were calculated as well as newly proposed TAVI risk scores (TAVI2-SCORe, STT Score and OBSERVANT score). Medium-term survival of the patients was assessed up to 1 year after TAVI. RESULTS: The median age was 82 (77-86) years and 45.3% were male. Patients were categorized into 'non-high risk' or 'high risk' according to logistic EuroSCORE >20%, EuroSCORE II >8%, STS score >10%, TAVI2-SCORe >2, STT score >12% and OBSERVANT score >6. Thirty-day and 1-year survival rates were significantly different between 'non-high-risk' and 'high-risk' patients according to the STS score (1 year: low: 84.4% vs high: 67.0%, P = 0.010) and according to OBSERVANT score (1 year: low: 85.2% vs high: 68.4%, P = 0.005). In contrast, TAVI2-SCORe and STT score did not discriminate 'non-high-risk' and 'high-risk' patients. This was confirmed by Cox regression analysis [STS score >10%: hazard ratio: 2.484 (1.206-5.115), P = 0.014; OBSERVANT score >6: hazard ratio: 2.532 (1.295-4.952), P = 0.007]. CONCLUSIONS: In this single-centre study, OBSERVANT and STS score most accurately predicted early and mid-term survival in patients undergoing TAVI, using a self-expandable valve (CoreValve).

Red cell distribution width improves the prediction of prognosis after transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to determine if red cell distribution width (RDW) could improve the prediction of prognosis after transcatheter aortic valve implantation (TAVI). METHODS: In this single-centre study, 197 consecutive patients underwent TAVI (median age 82 (77-86), 46.2% men). Normal RDW at baseline was defined as ≤15.5%, elevated RDW at baseline was defined as >15.5%. Ouctomes according to the Valve Academic Research Consortium 2 and survival up to one year were compared between these groups. RESULTS: Compared with the patients with RDW ≤15.5% (n = 168), those with RDW >15.5% (n = 29) had a higher Society of Thoracic Surgeon (STS) score (7.2 vs 5.0%, P = 0.041), higher systolic pulmonary arterial pressure (50 vs 41 mmHg, P = 0.021) and lower haemoglobin (11.5 vs 12.4 mg/dl, P = 0.003). Patients with RDW >15.5% developed significantly more adverse events after TAVI (major vascular complications: 10.3 vs 1.8%, P = 0.042; aortic regurgitation grade II-IV: 50.0 vs 18.0%, P = 0.001) and survival up to 1 year was significantly lower (85.6 vs 65.2%, log-rank: P = 0.007). In addition, RDW >15.5% at baseline was the most significant predictor for mortality (hazard ratio: 2.701 (1.279-5.704), P = 0.009), even when the STS score was added to the model [RDW >15.5%: hazard ratio: 2.276 (1.045-4.954), P = 0.038]. CONCLUSIONS: Elevated RDW is a significant predictor for adverse events and increased 1-year mortality after TAVI. Adding RDW to the classical STS score could be a valuable strategy to improve preoperative risk assessment in potential TAVI candidates.

Brachiocephalic artery access in transcatheter aortic valve implantation: a valuable alternative: 3-year institutional experience.

OBJECTIVES: With the expanding use of transcatheter aortic valve implantation (TAVI), we have encountered increasing numbers of patients without ideal femoral access. Although many alternatives have been described, vascular access and access-related complications remain a point of concern. We report our series of 20 patients undergoing TAVI via brachiocephalic artery access. METHODS: Between September 2011 and May 2014, we performed 107 consecutive CoreValve bioprosthesis implantations, of which 20 were by the brachiocephalic approach due to unfavourable iliac or femoral anatomy. RESULTS: No vascular or access-related complications were seen. Procedural feasibility, device success and early safety, as defined by the Valve Academic Research Consortium-2 criteria, were good, at 100, 95 and 95%, respectively. No stroke, transient ischaemic attack, acute kidney injury, major vascular or major bleeding complications were observed. At a mean follow-up of 497 days, the 1-year survival rate is 75.0%. Echocardiography at discharge confirmed moderate paravalvular regurgitation in 1 patient and mild paravalvular leakage in 3 patients, and no paravalvular leak more than moderate was seen. Echocardiography at discharge, 6 months and 1 year after TAVI confirmed persistent low mean transvalvular gradients (9, 9 and 10 mmHg, respectively). CONCLUSIONS: TAVI implantation through the brachiocephalic artery is safe and feasible. The distance between the point of access and the aortic valve annulus is short, improving catheter stability and implant site accuracy. We consider it to be a valuable alternative in patients without femoral access.

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.

Aortic regurgitation after transcatheter aortic valve implantation (TAVI) - Angiographic, echocardiographic and hemodynamic assessment in relation to one year outcome.

BACKGROUND: Aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) remains a relatively frequent and life-limiting complication. However, the most prognostically discriminative (and therefore preferred) technique of AR evaluation after TAVI is not yet clearly defined. The aim of this study was to compare angiographic, echocardiographic and hemodynamic assessment of AR after TAVI in relation to one year outcome. METHODS AND RESULTS: In this single center prospective cohort study, angiography (AR grading), echocardiography (AR quantification using color Doppler flow mapping) and invasive hemodynamics (AR index) were assessed before and after TAVI. All patients were followed up to at least one year. A total of 111 consecutive (very) high-risk patients with severe, symptomatic aortic valve stenosis underwent TAVI. No concordant relation could be demonstrated between angiographic, echocardiographic and invasive assessment of AR after TAVI. AR index <25 post TAVI was significantly influenced by left ventricular posterior wall thickness (odds ratio: 1.276, p=0.030) and AR index pre TAVI (odds ratio: 0.948, p=0.019). Neither angiographic nor hemodynamic AR assessments were able to discriminate between good or significantly decreased one year survival. In contrast, color Doppler flow mapping of AR after TAVI was highly reproducible, and able to differentiate between good or significantly decreased one year survival (AR grades 0-I: one year survival 87% vs. AR grades II-III-IV: one year survival 68%, p=0.035). CONCLUSION: Echocardiography using color Doppler flow mapping is the preferred technique to assess prognostically relevant AR after TAVI.

Depth of valve implantation, conduction disturbances and pacemaker implantation with CoreValve and CoreValve Accutrak system for Transcatheter Aortic Valve Implantation, a multi-center study.

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is now considered an indispensable treatment strategy in high operative risk patients with severe, symptomatic aortic stenosis. However, conduction disturbances and the need for Permanent Pacemaker (PPM) implantation after TAVI with the CoreValve prosthesis still remain frequent. METHODS AND RESULTS: We aimed to evaluate the implantation depth, the incidence and predictors of new conduction disturbances, and the need for PPM implantation within the first month after TAVI, using the new Accutrak CoreValve delivery system (ACV), compared to the previous generation CoreValve (non-ACV). In 5 experienced TAVI-centers, a total of 120 consecutive non-ACV and 112 consecutive ACV patients were included (n=232). The mean depth of valve implantation (DVI) was 8.4±4.0 mm in the non-ACV group and 7.1±4.0 mm in the ACV group (p=0.034). The combined incidence of new PPM implantation and new LBBB was 71.2% in the non-ACV group compared to 50.5% in the ACV group (p=0.014). DVI (p=0.002), first degree AV block (p=0.018) and RBBB (p<0.001) were independent predictors of PPM implantation. DVI (p<0.001) and pre-existing first degree AV-block (p=0.021) were identified as significant predictors of new LBBB. CONCLUSION: DVI is an independent predictor of TAVI-related conduction disturbances and can be reduced by using the newer CoreValve Accutrak delivery system, resulting in a significantly lower incidence of new LBBB and new PPM implantation.