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In the first three months after Transcatheter aortic valve implantation (TAVI), a remarkable number of patients have an unfavorable outcome. An inflammatory response after TAVI is suspected to have negative effects. The exact mechanisms remain unclear. We examined the influence of monocyte subpopulations on the clinical outcome, along with the degree of monocyte activation and further parameters of inflammation and platelet activation. Flow-cytometric quantification analyses of peripheral blood were done in 120 consecutive patients who underwent TAVI (one day before TAVI and on day 1 and 7 after TAVI). Monocyte-subsets were defined by their CD14 and CD16 expression, monocyte-platelet-aggregates (MPA) by CD14/CD41 co-expression. The extent of monocyte activation was determined by quantification of CD11b-expression (activation epitope). Additionally, pro-inflammatory cytokines such as interleukin (IL)-6, IL-8, C-reactive protein were measured with the cytometric bead array method or standard laboratory tests. Elevated Mon2 (CD14++CD16+) - monocytes (38 vs. 62 cells/μl, p < 0.001) and a high expression of CD11b prior to TAVI (MFI 50.1 vs. 84.6, p < 0.05) were independently associated with death 3 months after TAVI. Mon2 showed the highest CD11b-expression and CD11b correlated with platelet activation and markers of systemic inflammation. Even CRP and IL-8 before TAVI were associated with death after TAVI. In contrast, a systemic inflammation response shortly after TAVI was not associated with early death. Elevated Mon2-monocytes and a high level of monocyte activation before TAVI are associated with early mortality after TAVI. Chronic inflammation in aging patients seems to be an important risk factor after TAVI. • An elevated content of Mon2 monocytes are associated with death after TAVI. • CD11b-expression on monocytes, as sign of enhanced cellular activity before TAVI, are associated with death after TAVI as well. • Mon2 and CD11b before TAVI may disclose a use as biomarkers and function as possible therapeutic targets in the future. • A systemic inflammatory response shortly after TAVI was not associated with worse outcome. • The kind of inflammation and the involved cells rather than the extent itself determines the survival after TAVI. [ABSTRACT FROM AUTHOR]

Several mortality prediction models (MPM) are used for predicting early (30-day) mortality following transcatheter aortic valve implantation (TAVI). Little is known about their predictive performance in external TAVI populations. We aim to externally validate established MPMs on a large TAVI dataset from the Netherlands Heart Registration (NHR). We included data from NHR-patients who underwent TAVI during 2013–2017. We calculated the predicted mortalities per MPM. We assessed the predictive performance by discrimination (Area Under Receiver Operating-characteristic Curve, AU-ROC); the Area Under Precision-Recall Curve, AU-PRC; calibration (using calibration-intercept and calibration-slope); Brier Score and Brier Skill Score. We also assessed the predictive performance among subgroups: tertiles of mortality-risk for non-survivors, gender, and access-route. We included 6177 TAVI-patients with an observed early-mortality rate of 4.5% (n = 280). We applied seven MPMs (STS, EuroSCORE-I, EuroSCORE-II, ACC-TAVI, FRANCE-2, OBSERVANT, and German-AV) on our cohort. The highest AU-ROCs were 0.64 (95%CI 0.61–0.67) for ACC-TAVI and 0.63 (95%CI 0.60–0.67) for FRANCE-2. All MPMs had a very low AU-PRC of ≤0.09. ACC-TAVI had the best calibration-intercept and calibration-slope. Brier Score values ranged between 0.043 and 0.063. Brier Skill Score ranged between −0.47 and 0.004. ACC-TAVI and FRANCE-2 predicted high mortality-risk better than other MPMs. ACC-TAVI outperformed other MPMs in different subgroups. The ACC-TAVI model has relatively the best predictive performance. However, all models have poor predictive performance. Because of the poor discrimination, miscalibration and limited accuracy of the models there is a need to update the existing models or develop new TAVI-specific models for local populations. • Existing MPMs have different ability in predicting early-mortality after TAVI. • Existing MPMs had poor predictive performance in external TAVI population. • Using such MPMs outside the original population is questionable. • Developing TAVI-specific MPM (preferably global model) is a need. [ABSTRACT FROM AUTHOR]

The capacity of TAVI-programs and numbers of sites performing TAVI has rapidly increased. This necessitated the initiation of the Rotterdam TAVI Care & Cure Program, aiming to improve patient-centered care during the TAVI pathway. Consenting patients with severe aortic stenosis and an indication for TAVI will be included. The TAVI Care & Cure program will facilitate prognostic contributions to improve outcomes, patient satisfaction and quality of life in patients with valvular heart disease who are treated with a transcatheter aortic valve implantation in collaboration with the departments of cardiology, cardio-thoracic surgery, anesthesiology and geriatrics. With a single center observational registry, we aim to assess the TAVI patient clinical pathway, focusing on pre, peri and post interventional variables including functional status and HRQoL. We will evaluate the patient's complexity by applying an extended multidisciplinary approach, which includes a systematic application of geriatric assessments of frailty and cognitive function. • To create a novel comprehensive patient centred pathway for patients eligible for TAVI. • To create an enhanced multi disciplinary heart team with the addition of the department of geriatrics. • To improve risk stratification and patient selection for transcatheter aortic valve implantation. • To predict more distinctly the differentiation between those patients who will benefit from TAVI and those who will not. • To access potential parameters applicable for an early discharge strategy. [ABSTRACT FROM AUTHOR]

Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). Among 628 patients (mean age 82.4 ± 5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4–8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93–1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01–1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18–60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases. • The occurrence of structural valve deterioration (SVD) is rare (<2%). • SVD is diagnosed on average 3.5 years after the index procedure. • Comparing valve-types, no differences in all-cause mortality or stroke can be seen. • Repeat interventions for prosthetic heart valve related problems occur sporadically. [ABSTRACT FROM AUTHOR]

Objective To assess soluble suppression of tumorigenicity 2 (sST2) serum concentrations and predict mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Methods We prospectively enrolled 74 patients with severe aortic stenosis (AS) who underwent TAVI and matched them to patients without aortic valve disease (n = 74). AS patients underwent comprehensive echocardiographic and cardiac magnetic resonance imaging and laboratory examinations. sST2 levels were determined by enzyme-linked immunosorbent assay (ELISA), their association with post procedural mortality was investigated using logistic and Cox regression analyses, and the prognostic performance compared to established risk scores. Results AS patients had substantially higher sST2 levels than controls (39.5 vs. 17.8 ng/mL, p < 0.001). sST2 significantly correlated with left and right atrial sizes (r = 0.25, p = 0.033 and r = 0.38, p = 0.001). At one and two years, 10 (13.9%) and 18 (25%) patients had died, respectively. sST2 significantly predicted survival in uni- and multivariate Cox regression analyses in our cohort (p = 0.005 and p = 0.025). sST2 also predicted major adverse cardiovascular events (MACE, p = 0.046). Adding sST2 to the established STS score improved prediction of two-year mortality in our cohort (ΔAUC = 0.108; 95% CI − 0.066–0.281; continuous NRI = 0.778; 95% CI: 0.277–1.278 and IDI = 0.141; 95% CI: 0.031–0.251), and a model containing both sST2 and the STS score had a negative predictive value of 96.1% and 86.3% regarding one and two-year mortality, respectively. Conclusions sST2 is elevated in AS patients and a prognostic marker of survival after TAVI. Implementation of this marker in routine pre-TAVI workup may improve risk prediction and patient selection. [ABSTRACT FROM AUTHOR]

Aims Pulmonary hypertension (PH) is associated with mortality after transcatheter aortic valve implantation (TAVI). However, diagnosis based on tricuspid regurgitant velocity (TRV) is often inaccurate and unreliable. The updated PH guidelines introduced a PH probability grading implementing additional PH signs on transthoracic echocardiography (TTE), from which we aimed to analyse its effects on clinical outcomes in patients undergoing TAVI. Methods and results We included 591 consecutive patients (mean age 80.2 ± 8.4 years, 58.0% female, mean STS risk score 6.2 ± 3.8%) undergoing TAVI. Patients were divided into “low” ( n = 270; TRV ≤ 2.8 m/s without additional PH signs), “intermediate” ( n = 131; TRV ≤ 2.8 m/s with additional PH signs, or TRV 2.9–3.4 m/s without additional PH signs), and “high” PH probability ( n = 190; TRV 2.9–3.4 m/s with additional PH signs, or TRV > 3.4 m/s). The overall 30-day and 2-year mortality rates were 10.2% and 33.8%, respectively. “High” PH probability was an independent predictor of mortality at 30 days (HR 3.68, 95% CI 2.03 to 6.67, p < 0.01) and 2 years (HR 2.19, 95% CI 1.57 to 3.04, p < 0.01), compared to “low” PH probability. The “intermediate” group did not show an increased risk. The presence of additional PH signs resulted in a significantly higher mortality at 30 days (19.6% vs. 5.1%, p < 0.01) and two years (54.2% vs. 22.5%, p < 0.01). Conclusions The updated echocardiographic PH probability model incorporating additional PH signs independently predicts early and late mortality after TAVI. Additional PH signs are of great value in assessing one's risks since its presence is strongly associated with early and late mortality. [ABSTRACT FROM AUTHOR]

Background To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system. Methods Twenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2 ± 8.2% (mean age 74.5 ± 4.7 years). Four sizes of prosthesis were used for annular size up to 21 mm (n = 1), 23 mm (n = 2), 25 mm (n = 10) and 27 mm (n = 7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance. Results TAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3 ± 8.5 vs. 16.4 ± 13.3 mm Hg, P < 0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9 ± 1mm Hg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation. Conclusion Trans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. [ABSTRACT FROM AUTHOR]

Objective We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). Background BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. Methodology We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint -- a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year. Results A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%) -- mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3 + occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality -- Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. Conclusion In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: Background: The complex anatomy of the aortic annulus warrants the use of three dimensional (3D) modalities for prosthesis sizing in transcatheter aortic valve implantation (TAVI). Multislice computed tomography (MSCT) has been used for this purpose, but its use may be restricted because of contrast administration. 3D transesophageal echocardiography (3D-TEE) lacks this limitation and data on comparison with MSCT is scarce. We compared 3D-TEE with MSCT for prosthesis sizing in TAVI. Methods: Aortic annulus diameters in the sagittal and coronal plane and annulus areas in 3D-TEE and MSCT were compared in 57 patients undergoing TAVI. Final prosthesis size was left at the operator's discretion and the agreement with 3D-TEE and MSCT was calculated. Results: Sagittal diameters on 3D-TEE and MSCT correlated well (r=.754, p<.0001) and means were comparable (22.3±2.1 vs. 22.5±2.3mm; p=0.2; mean difference: −0.3mm [−3.3–2.8]). On 3D-TEE, coronal diameter and annulus area were significantly smaller (p<.0001 for both) with moderate correlation (r=0.454 and r=0.592). Interobserver variability was comparable for both modalities. TAVI was successful in all patients with no severe post-procedural insufficiency. Final prosthesis size was best predicted by sagittal annulus diameters in 84% and 79% by 3D-TEE and MSCT, respectively. Agreement between both modalities was 77%. Conclusions: Annulus diameters and areas for pre-procedural TAVI assessment by 3D-TEE are significantly smaller than MSCT with exception of sagittal diameters. Using sagittal diameters, both modalities predicted well final prosthesis size and excellent procedural results were obtained. 3D-TEE can thus be a useful alternative in patients with contraindications to MSCT. [Copyright &y& Elsevier]

Abstract: Aims: Prospective data on the usage of 3-dimensional imaging based annulus sizing on the outcome of TAVI is not available yet and there is general uncertainty about the optimal degree of oversizing. In the current study we therefore assessed a 3-D MSCT guided over-sizing approach and evaluated the clinical outcome of different degrees of oversizing. Methods: TAVI-size-selection was done using systolic MSCT-annulus cross-sectional-area (CSA) measurements in 107 patients with severe aortic stenosis with the goal to oversize the 3rd generation balloon expandable Edwards Sapien XT (ESTV) device in relation to the native aortic annulus CSA. Results: Among different degrees of oversizing there were no differences in the occurrence of stroke, myocardial infarction and death. No aortic injuries were observed. The overall rate of >mild postprocedural aortic regurgitation (PAR) was 7.6%. Increasing oversizing ratios are associated with lower rates of >mild PAR (r=−0.236, p<0.02) with the lowest rate of >mild PAR in patients with area based oversizing ratios >25% and the highest rate in patients with oversizing ratios <15% (0% vs. 15.8%, p<0.02). The rate of postprocedural permanent pacemakers tended to be lower in patients with <15% oversizing compared to those with >25% oversizing (5.3 vs. 16.7%, p<0.23). Conclusions: MSCT guided ESTV-device sizing is safe and is associated with significantly lower than previously reported rates for PAR. A device/annulus oversizing ratio of 15–25% based on area and 7–12% based on mean diameter appears to provide the best risk-benefit ratio in terms of PAR reduction and conduction disorders. [Copyright &y& Elsevier]

Abstract: Background/objectives: To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Methods: Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30bpm) or absent ventricular escape rhythm during follow-up PM interrogation. Results: A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady–tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40months (median (IQR): 11.5 (5.0–18.0months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Conclusion: Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. [Copyright &y& Elsevier]

Background: To determine the prognostic value of pro B-type natriuretic peptide (pro-BNP) to predict mortality after transcatheter aortic valve implantation (TAVI). Logistic EuroSCORE (LES) overestimates observed mortality after TAVI. A new risk score specific to TAVI is needed to accurately assess mortality and outcome. Methods: Eighty-five patients were included. Indications for TAVI were nonoperable or surgically high-risk patients (LES>20%). Pro-BNP was measured 24h before the procedure. Cox proportional hazards model was used to evaluate clinical factors. The predictive accuracy of these Cox models was determined by using time-dependent receiver operating characteristic (ROC) curves. Results: Pro-BNP levels (log-transformed) were significantly higher in non-survivors than in survivors at 30days (3.36±0.43 vs. 3.81±0.43, p<0.004) and at the end of follow-up (3.34±0.42 vs. 3.63±0.48, p<0.011). Multivariate analysis revealed that only increased log pro-BNP levels were associated with higher mortality rate at short [hazard ratio (HR) (95% confidence intervals (CI)]=5.35 (1.74–16.5), p=0.003] and long-term follow-ups [HR=11 (CI: 1.51–81.3), p=0.018]. LES was not associated with increased mortality at either time point [HR=1.03 (CI: 0.95–1.10), p=0.483 and HR=1.03 (CI: 0.98–1.07), p=0.230, respectively]. At 30, 90, 180, and 365days, the c-index was 0.72 for log pro-BNP and 0.63 for LES (p=0.044). Conclusion: Pre-procedure log transform of plasma pro-BNP levels are an independent and strong predictor of short- and long-term outcomes after TAVI and are more discriminatory than LES. [ABSTRACT FROM AUTHOR]