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Background: 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. Methods: 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. Conclusion: 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.

This Review discusses the evolving indications of transcatheter aortic valve implantation (TAVI), including the latest clinical trials in young and low-risk patients with symptomatic severe aortic stenosis and ongoing studies exploring TAVI for other indications, including severe bicuspid aortic valve stenosis and pure native aortic regurgitation, highlighting procedural implications and caveats of new and future indications.Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.

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. (c) 2020 by the American College of Cardiology Foundation.

Background: Vascular complications (VCs) after transcatheter aortic valve implantation (TAVI) are associated with impaired outcome. We performed a meta-analysis to determine in-hospital/30-day majo...

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.

Background: Myocardial injury (MI) is common with transcatheter aortic valve implantation (TAVI) and may predict poor outcome. We aim: 1) to evaluate the difference in change of high-sensitivity-Tr...

We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation.We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography (primary analysis) and transthoracic echocardiography (secondary analysis). In mildly calcified roots paravalvular regurgitation incidence was similar for all transcatheter heart valves (SEV 8.4%; BEV 9.1%; MEV 2.0% p = 0.27). Conversely, in heavily calcified roots paravalvular regurgitation incidence was significantly higher with SEV (SEV 45.9%; BEV 0.0%; MEV 0.0% p 0.001). When paravalvular regurgitation was assessed by TTE, the overall findings were similar although elliptic aortic roots were associated with more paravalvular regurgitation with SEV (20.5% vs. BEV 4.5% vs. MEV 3.2%; p = 0.009).In heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones. These findings may support patient-tailored transcatheter heart valve selection.Aortic stenosis; multislice computed tomography; transcatheter aortic valve replacement; paravalvular aortic regurgitation.We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography and transthoracic echocardiography. We found that in heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones.

Transcatheter aortic valve implantation has become an established procedure to treat severe aortic stenosis. Correct device sizing/positioning is crucial for optimal outcome. Lotus valve sizing is based upon multiple aortic root dimensions. Hence, it often occurs that two valve sizes can be selected. In this study, patient-specific computer simulation is adopted to evaluate the influence of Lotus size/position on paravalvular aortic regurgitation (AR) and conduction abnormalities, in patients with equivocal aortic root dimensions. First, simulation was performed in 62 patients to validate the model in terms of predicted AR and conduction abnormalities using postoperative echocardiographic, angiographic and ECG-based data. Then, two Lotus sizes were simulated at two positions in patients with equivocal aortic root dimensions. Large valve size and deep position were associated with higher contact pressure, while only large size, not position, significantly reduced the predicted AR. Despite general trends, simulations revealed that optimal device size/position is patient-specific.

Transcatheter aortic valve replacement (TAVR) is the gold standard for severe valvular aortic stenosis in patients at high/prohibitive surgical risk. This procedure has also been used in patients with previous mitral valve (MV) prostheses, with contrasting outcomes reported. The aim of this study is to describe procedural and early outcomes of patients with previous MV prostheses undergoing TAVR.This is a retrospective registry of 154 patients with previous MV prostheses who underwent TAVR across high-volume medical centres at a mean of 11.7 ± 8.4 years after mitral surgery.Mean mitroaortic distance at computed tomography was 9.7 ± 4.8 mm. Procedural success was achieved in 150 (97.4%) patients, with reduction of aortic gradients (42.6 ± 14.2 to 10.0 ± 7.0 mm Hg; P0.001). Device success was achieved in 133 (86.3%) patients. MV prosthesis interference by the TAVR device was observed in 2 patients; in both, the mitroaortic distance was5 mm, with 1 complicated by TAVR prosthesis embolization. Periprocedural complications included 4 (2.6%) cerebrovascular accidents, 10 (6.6%) major vascular complications, 22 (14.4%) severe bleedings, 1 (0.7%) myocardial infarction, and 5 (3.2%) in-hospital deaths (all cases cardiovascular or procedure related). At a median follow-up of 13.5 (interquartile range 1.0 to 36.0) months, 26 (16.9%) deaths occurred; 15 (9.7%) were cardiac related. Late fatal mitral prosthesis thromboses occurred in 2 patients. We recorded a case of fatal hemorrhagic stroke; hospital readmission was observed in 25 (16.2%) patients due to worsening heart failure.TAVR in patients with previous mitral prostheses appears to be safe and feasible, with good hemodynamic results at 30-day and at longer-term follow-up.

Frailty in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) has been associated with an increased 1-year mortality rate but the relation of frailty and short term outcomes yields conflicting results. This study investigated the association of a novel and self-developed Erasmus Frailty Score with both short and long term outcomes after TAVI.TAVI CareCure is an observational ongoing study, which includes consecutive patients undergoing TAVI at the Erasmus University Medical Centre. Prior to the TAVI, frailty status was assessed. The Erasmus Frailty Score (EFS) was defined as follows: 1 point assigned if: MMSE was27 points, MUST ≥2 points, grip strength20 kg for females,30 kg for males, KATZ index ≥1 limited activity, Lawton and Brody index ≥2 limited activity. The maximum score was 5. Patients were classified as frail when the score was ≥3. Presence of delirium was evaluated by daily clinical assessment by a geriatrician pre- and post-TAVI. Mortality data were obtained from the Dutch Civil Registry. The impact of frailty on short and long term outcomes was evaluated.213 patients were included for analysis. Frailty was present in 28.6% (n = 61), (EFS ≥ 3). Baseline frailty was associated with patients developing a delirium [OR 3.3 (95% CI 1,55-7,10), p = 0.002] and with increased risk of 1-year mortality [HR 2.1 (95% CI 1.01-4.52), p = 0.047].The Erasmus Frailty Score is associated with delirium and 1 year mortality in older patients after TAVI and can be used as a complement to traditional risk factors.

Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function.This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls).The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P0.001), with a greater effect among RTRs than controls (P for interaction = 0.022).s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.

Background: Dedicated data on the prevalence of incidental findings (IF) stratified according to overall clinical relevance and their subsequent correlation to outcome are lacking. The aim of the present study was to describe the prevalence and consequences of noncardiac IF on computed tomography or magnetic resonance imaging in the workup for interventional cardiovascular procedures. Methods: A total of 916 patients underwent preprocedural computed tomography or magnetic resonance imaging in the workup for transcatheter aortic valve implantation (TAVI), renal sympathetic denervation (RDN), or MitraClip implantation. Results: IF were found in 395 of 916 patients (43.1%), with an average of 1.8 IF per patient. Classifying the IF resulted in 155 patients with minor, 171 patients with moderate, and 69 patients with major IF. The intended procedure was delayed or canceled in only 15 of 916 (1.6%) of the patients because of the presence of potential malignant IF. In patients that did undergo the intended procedure (n = 774), the presence of a moderate or major IF (23.8%) did not impact 1-year mortality compared to no or minor IF (adjusted HR 0.90, 95% CI 0.56-1.44, P value =.65). These findings were consistent among patients referred for TAVI, RDN, or MitraClip. Conclusions: IF are frequent in patients referred for cardiovascular procedures. IF did not result in a delay or cancellation of the intended procedure in the vast majority of cases, irrespective of their clinical relevance. The presence of a major or moderate IF did not significantly impact 1-year mortality.

Background: We aimed to compare the rate of neurological events in patients with or without cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Methods and Results: Data on clinical end points including neurological events ≤30 days post-TAVR were collected for all patients who underwent transfemoral TAVR in 2 academic tertiary care institutions. Patients were matched through propensity scoring, which resulted in 333 pairs of patients with versus without CEP out of a total of 831 consecutive patients. The median age was 81 (76–85) years, and the median logistic EuroScore was 14% (9%–20%). The CEP group experienced less neurological events at 24 hours (1% versus 4%; P =0.035) and at 30 days (3% versus 7%; P =0.029). There were significantly more disabling strokes in unprotected patients at 30 days (1% versus 4%; P =0.039). CEP was associated with significantly fewer neurological events at 24 hours after TAVR (odds ratio, 0.20; 95% CI, 0.06–0.73; P =0.015) by multiple regression analysis, while age and valve type did not contribute significantly. Overall, 67% (2 of 3) in the CEP versus 83% (10 of 12) in the non-CEP cohort experienced neurological events in protected areas (ie, not dependent on the left vertebral artery). Conclusions: The use of filter-based CEP during TAVR was associated with less neurological events, especially in CEP-protected brain territories.

Background: A patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in tricuspid aortic valve has been developed, which can predict paravalvular regurgitation and conduction disturbance. We wished to validate a patient-specific computer simulation of TAVR in bicuspid aortic valve and to determine whether patient-specific transcatheter heart valve (THV) sizing and positioning might improve clinical outcomes. Methods: A retrospective study was performed on TAVR in bicuspid aortic valve patients that had both pre- and postprocedural computed tomography imaging. Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis and computational fluid dynamics was performed. The simulation output was compared with postprocedural computed tomography imaging, cineangiography, echocardiography, and electrocardiograms. For each patient, multiple simulations were performed, to identify an optimal THV size and position for the patient’s specific anatomic characteristics. Results: A total of 37 patients were included in the study. The simulations accurately predicted the THV frame deformation (minimum-diameter intraclass correlation coefficient, 0.84; maximum-diameter intraclass correlation coefficient, 0.88; perimeter intraclass correlation coefficient, 0.91; area intraclass correlation coefficient, 0.91), more than mild paravalvular regurgitation (area under the receiver operating characteristic curve, 0.86) and major conduction abnormalities (new left bundle branch block or high-degree atrioventricular block; area under the receiver operating characteristic curve, 0.88). When compared with the implanted THV size and implant depth, optimal patient-specific THV sizing and positioning reduced simulation-predicted paravalvular regurgitation and markers of conduction disturbance. Conclusions: Patient-specific computer simulation of TAVR in bicuspid aortic valve may predict the development of important clinical outcomes, such as paravalvular regurgitation and conduction abnormalities. Patient-specific THV sizing and positioning may improve clinical outcomes of TAVR in bicuspid aortic valve.

Background: Both aortic valve stenosis as aortic stiffness are moderators of arterio-ventricular coupling and independent predictors of cardiovascular morbidity and mortality. Studies on the effect of Transcatheter Aortic Valve Implantation (TAVI) on hemodynamic parameters are limited. We performed a pilot study to investigate possible short-term hemodynamic changes after TAVI in older patients. Methods: TAVI Care & Cure is an observational ongoing study including consecutive patients undergoing TAVI procedure. Central and peripheral hemodynamic measurements were measured non-invasively 1 day before (T0) and 1 day after (T1) TAVI using a validated oscillometric method using a brachial cuff (Mobil-O-Graph). Results: 40 patients were included. Mean aortic valve area at baseline was 0.73 ± 0.18 cm2. As expected indices of severity of the aortic valve stenosis improved. Systolic blood pressure (SBP) dropped by 8.5%, from 130.3 ± 22.9 mmHg to 119.5 ± 15.8 mmHg (p = 0.005). Diastolic blood pressure (DBP) dropped by 13.1 % from 74.8 ± 14.5 mmHg to 65.0 ± 11.3 mmHg (p < 0.001). The aPulse Wave Velocity (aPWV) decreased from 12.05 ± 1.99 m/s to 11.6 ± 1.56 m/s (p = 0.006)(Fig. 1). Patients with high aPWV at baseline showed a significantly larger reduction in SBP in comparison to patients with low aPWV: − 20.3 mmHg (−14,1%) vs – 3,1 mmHg (−2.6%), respectively (p = 0.033). The same trend was found for the DBP: −16.2 (−20.4%) v.s. −4.5 mmHg (−6.3%) for high vs. low aPWV at baseline (p=0.037). Conclusion: We found short term changes of blood pressure and aortic stiffness after TAVI. The amplitude of the changes was the largest in patients with elevated aortic stiffness at baseline.

To study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including 179 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with either the Medtronic CoreValve (MCS), Edward-SAPIEN Valve (ESV), Boston Sadra Lotus (BSL) or Saint-Jude Portico Valve (SJP) in whom rotational angiography (R-angio) with motion compensation 3D image reconstruction was performed. Image quality was evaluated from grade 1 (excellent image quality) to grade 5 (strongly degraded). Distinction was made between good (grades 1, 2) and poor image quality (grades 3-5). Clinical (gender, body mass index, Agatston score, heart rate and rhythm, artifacts), procedural (valve type) and technical variables (isocentricity) were related with the image quality assessment. Image quality was good in 128 (72 %) and poor in 51 (28 %) patients. By univariable analysis only valve type (BSL) and the presence of an artefact negatively affected image quality. By multivariate analysis (in which BMI was forced into the model) BSL valve (Odds 3.5, 95 % CI [1.3-9.6], p = 0.02), presence of an artifact (Odds 2.5, 95 % CI [1.2-5.4], p = 0.02) and BMI (Odds 1.1, 95 % CI [1.0-1.2], p = 0.04) were independent predictors of poor image quality. Rotational angiography with motion compensation 3D image reconstruction using a dedicated research prototype software offers good image quality for the evaluation of frame geometry after TAVI in the majority of patients. Valve type, presence of artifacts and higher BMI negatively affect image quality.

Resumen Introduccion y objetivos Se sabe que los factores relacionados con el paciente y con la intervencion se asocian con insuficiencia aortica despues de un implante percutaneo de valvula aortica. No obstante, tambien puede causarla una interaccion especifica entre el dispositivo y el huesped como consecuencia de las propiedades biomecanicas de las valvulas, con independencia de los factores clinicos. El objetivo de este estudio es esclarecer el papel de la geometria de la valvula en la aparicion de insuficiencia aortica despues del implante de las valvulas Medtronic CoreValve® y Edwards SAPIEN®. Metodos Se llevo a cabo un estudio observacional que incluyo a 134 pacientes tratados con implante percutaneo de valvula aortica empleando las valvulas Medtronic CoreValve® y Edwards SAPIEN®. El analisis geometrico se realizo en tres niveles predefinidos de ambas valvulas mediante angiografia rotacional con compensacion de movimiento usando un programa informatico especificamente desarrollado para este fin. Se establecio una distincion entre los pacientes con insuficiencia aortica nula o leve y los pacientes con insuficiencia aortica moderada o grave segun la ecocardiografia. Resultados Las caracteristicas basales eran similares con ambas valvulas. A pesar del mayor uso de predilatacion en el grupo de CoreValve® (el 95,2 frente al 82,0%; p = 0,012), el mayor exceso de tamano de protesis/anillo aortico (perimetro, el 114 ± 7% frente al 103 ± 7%; p Conclusiones Independientemente de los factores relacionados con el paciente y con la intervencion, existe una interaccion entre dispositivo y huesped que es especifica del dispositivo y explica la insuficiencia aortica existente despues de un implante percutaneo de valvula aortica.

__Aims__ To correlate dynamics in electrical conduction after transcatheter aortic valve implantation (TAVI) with need for permanent pacemaker implantation (PPM) and assess implications for early discharge. __Methods and results__ Daily electrocardiograms after TAVI were analysed for rhythm and conduction times and were correlated with PPM. Transcatheter aortic valve implantation was performed in 291 consecutive patients with three contemporary transcatheter heart valve designs: Medtronic CoreValve (n = 111), Edwards Sapien XT (n = 29) and Sapien 3 (n = 72), and Boston Lotus (n = 79). We considered two cohorts: (A) Patients with normal baseline conduction; and (B) patients with pre-existent conduction disturbances. Based on QRS dynamics, three patterns were discerned: stable normal QRS duration, transient QRS prolongation, and persistent QRS prolongation. In Cohort B, QRS dynamics did not correlate with PPM. In contrast, in Cohort A, QRS dynamics and PPM appeared highly correlated. Neither patients with stable normal QRS duration (0/47), nor patients with transient QRS prolongation required PPM (0/26). All PPMs occurred in patients with persistent QRS prolongation until discharge (27/85). Persistent QRS prolongation was typically seen with Lotus and CoreValve, whereas stable normal QRS duration was typically seen with Sapien XT and Sapien 3. __Conclusion__ Three distinct patterns of QRS dynamics can be discerned after TAVI and their predictive probabilities for PPM strongly relate to the baseline conduction status. Patients with normal conduction at baseline and stable QRS duration after TAVI are potentially eligible for early discharge.

Excellent outcome after transcatheter aortic valve replacement (TAVR) is demonstrated by preserved transcatheter heart valve (THV) function at 2 to 5 years and intact structural integrity at 2 years [(1,2)][1]. Hypoattenuated leaflet thickening (HALT) appears in up to 40% by multislice computed

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; P =0.01) and contact pressure index (odds ratio, 1.52; confidence interval, 1.1–2.1; P =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.

Aims The Lotus and SAPIEN3 are second-generation transcatheter heart valves, which are designed to minimize paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement (TAVR). We sought to compare both devices for valve performance and with emphasis on PAR by independent core laboratory analysis. Methods and results A total of 162 (79 Lotus and 83 SAPIEN3) consecutive patients (51% female, 80 ± 8 years, Logistic EuroSCORE 14.8 ± 9.4%) who underwent TAVR because of aortic stenosis were included. Patients with aortic valve-in-valve treatment were excluded. Pre-discharge echocardiograms were analysed by an independent core laboratory using the Valve Academic Research Consortium 2 criteria. There were no differences in baseline and procedural characteristics, except for a larger aortic annulus and sizing indices in SAPIEN3-treated patients and frequency of post-dilatation (0% in Lotus and 13.1% in SAPIEN3). Both valves have similar mean residual gradient, indexed effective orifice area and Doppler velocity index when adjusted to valve size. The frequency of mild (13.9% vs. 31.3%) and at least moderate (1.3% vs. 3.6%) PAR was less after Lotus than after SAPIEN3 implantation ( P = 0.02). Multi-slice computed tomography-based annulus and left ventricular outflow tract diameters, calcification and percentage of oversizing were not different between those with or without mild or more PAR. On multivariate analysis, the use of Lotus valve was associated with less (odds ratio OR, 0.41, P = 0.03) occurrence of PAR. Conclusion Overall, haemodynamic performance was comparable between the Lotus and SAPIEN3 valves. Lotus valve required less oversizing and was associated with less PAR than SAPIEN3.

Background: Aortic valve stenosis (AS) is common in the elderly and is associated with high morbidity and mortality, and leads to functional decline. The aim of this study was to investigate the possible relation between aortic stiffness, AS and frailty in older patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Methods: TAVI Care&Cure is an observational ongoing study including consecutive patients undergoing TAVI procedure at the Erasmus University Medical Center. Prior to TAVI echocardiography was performed and aortic stiffness was measured non-invasively by the Mobil-O-Graph. The frailty status was assessed including 5 domains. Primary outcome was to investigate the relationship between structural and functional cardiovascular parameters and frailty status. Linear regression was used. Results: A total of 212 patients were included for analysis. Mean age was 79,2 years (±7,8), 52,7% men, mean Aortic Valve Area (AVA) was 0,73 (± 0,3), mean Pulse Wave Velocity was 12,6 (±1,5). Frailty was found in 57,8%. Peripheral pulse pressure (p = 0.04) and central pulse pressure (p = 0.02) but not aortic stiffness were associated with AS severity. AVA was associated with frailty (p = 0.02) whereas measures of aortic stiffness were not. Conclusion: Aortic valve area but not measures of aortic stiffness is associated with frailty status in elderly patients with AS undergoing a TAVI procedure.

OBJECTIVES The aim of this study was to identify variables associated with tissue fragment embolization during transcatheter aortic valve replacement (TAVR). BACKGROUND Brain magnetic resonance imaging and transcranial Doppler studies have revealed that cerebrovascular embolization occurs frequently during TAVR. Embolized material may be r thrombotic, tissue derived, or catheter (foreign material) fragments. METHODS A total of 81 patients underwent TAVR with a dual filter–based embolic protection device (Montage Dual Filter System, Claret Medical, Inc., Santa Rosa, California) deployed in the brachiocephalic trunk and left common carotid artery. Both balloon-expandable and self-expanding transcatheter heart valves (THVs) were used. Filters were retrieved after TAVR and sent for histopathological analysis. RESULTS Overall, debris was captured in 86% of patients. Captured material varied in size from 0.1 to 9.0 mm. Thrombotic material was found in 74% of patients and tissue-derived debris in 63%. Tissue fragments were found more often with balloon-expandable THVs (79% vs. 56%; p ¼ 0.05). The embolized tissue originated from the native aortic valve leaflets, aortic wall, or left ventricular myocardium. On multivariable logistic regression analysis, balloonexpandable THVs (odds ratio: 7.315; 95% confidence interval: 1.398 to 38.289; p ¼ 0.018) and cover index (odds ratio: 1.141; 95% confidence interval: 1.014 to 1.283; p ¼ 0.028) were independent predictors of tissue embolization. CONCLUSIONS Debris is captured with filter-based embolic protection in the vast majority of patients undergoing TAVR. Tissue-derived material is found in 63% of cases and is more frequent with the use of balloon-expandable systems and more oversizing. (J Am Coll Cardiol Intv 2015;8:718–24) © 2015 by the American College of Cardiology Foundation.

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

The interaction of left ventricular outflow tract (LVOT) and transcatheter heart valve (THV) is complex and may be device design specific. We sought to study LVOT characteristics and its relation with permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR).We studied 302 patients with a median age of 81years [75-84]. Computed tomography was used to assess LVOT in terms of amount of calcium, perimeter and device size relative to LVOT.We implanted a Medtronic CoreValve (MCS) in 203 patients, Edwards-Sapien XT (ESV-XT) in 38, Edwards-Sapien S3 (ESV-S3) in 26 and Lotus in 35 patients. Sixty-eight patients (22.5%) received a new PPI within 30days after the index procedure. The incidence of PPI was 22.7% with MCS, 10.5% with ESV-XT, 26.9% with ESV-S3 and 31.4% with Lotus. By multivariate analysis RBBB at baseline (OR 2.9 [1.2-6.9, p=0.014), second generation valves (OR 2.1 [1.0-4.5], p=0.048), DOI (OR 1.20 per 1mm increment, [1.09-1.31], p0.001) and LVOT sizing (OR per 1% increment 1.03 [1.01-1.07], p=0.022) were associated with need for PPI. Sensitivity analyses suggest that a lesser degree of LVOT oversizing triggers PPI with second generation THVs vs. first generation THVs.More LVOT oversizing is associated with a higher need for permanent pacemaker implantation after TAVR, even more so with deeper THV implants and next generation devices (ESV-S3 and Lotus). Sizing algorithms should focus more on LVOT dimensions to reduce PPI.

AIMS Aortic regurgitation (AR) after Medtronic CoreValve System (MCS) implantation may be explained by patient-, operator- and procedure-related factors. We sought to explore if frame geometry, as a result of a specific device-host interaction, contributes to AR. METHODS AND RESULTS Using rotational angiography with dedicated motion compensation, we assessed valve frame geometry in 84 patients who underwent TAVI with the MCS. Aortic regurgitation was assessed by angiography (n=84, Sellers) and echocardiography at discharge (n=72, VARC-2). Twenty-two patients (26%) had AR grade ≥2 using contrast angiography, and 17 (24%) by echocardiography. Balloon predilatation and sizing and depth of implantation did not differ between the two groups. Despite more frequent balloon post-dilatation in patients with AR (40.9 vs. 9.7%, p=0.001), the frame was more elliptical at its nadir relative to the patient's annulus (6±13 vs. -1±11%, p=0.046) and occurred in a larger proportion of patients (61.9 vs. 26.8%, p=0.004). Although the Agatston score and the eccentricity of the MCS frame relative to the annulus were independent determinants of AR (odds ratio: 1.635 [1.151-2.324], p=0.006, and 4.204 [1.237-14.290], p=0.021), there was a weak association between the Agatston score and the adjusted eccentricity (Spearman's rank correlation coefficient =-0.24, p=0.046). CONCLUSIONS These findings indicate that AR can be explained by a specific device-host interaction which can only partially be explained by the calcium load of the aortic root.

Outcome of transcatheter aortic valve replacement (TAVR) depends on a combination of patient-, procedure-, and operator-related variables. Specific device–host-related interactions may also be involved and may result in, for instance, incomplete and/or nonuniform frame expansion that in turn may

Patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve morphology has previously been demonstrated to reliably predict the development of both paravalvular regurgitation (PVR) and conduction disturbance. We hypothesised that patient-specific

The efficacy of cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR) is unresolved. We aimed to compare the rates of neurological events and all-cause mortality after TAVR in patients with or without CEP. We studied all patients who underwent transfemoral TAVR with

Patient- and procedure-related factors are known to be associated with aortic regurgitation after transcatheter aortic valve implantation. Nevertheless, this entity may also be caused by a specific device-host interaction due to the biomechanical properties of the valves, independently of clinical factors. We sought to elucidate the role of frame geometry in the occurrence of aortic regurgitation after Medtronic CoreValve and Edwards SAPIEN valve implantation.We conducted an observational study encompassing 134 patients undergoing transcatheter aortic valve implantation with the Medtronic CoreValve and Edwards SAPIEN valve. Frame analysis was performed at 3 predefined levels of both valves by rotational angiography using dedicated motion compensation software. A distinction was made between patients with no-to-mild and moderate-to-severe aortic regurgitation by echocardiography.Baseline characteristics were similar between the 2 valves. Despite greater use of predilation in the CoreValve (95.2% vs 82.0%; P=.012), more oversizing (perimeter, 114±7% vs 103±7%; P.001), and the same depth of implantation (noncoronary sinus, 7±4 vs 8±2mm; left coronary sinus, 8±4 vs 8±2mm), it was less expanded and more eccentric than the Edwards SAPIEN (83±7% vs 92±4%; P.001 and 82±8% vs 95±3%; P.001, respectively) and when eccentricity was adjusted for the patient's annulus eccentricity (4±13% vs 21±11%; P.001). Eccentricity and adjusted eccentricity were associated with moderate-to-severe aortic regurgitation.Independently of patient- and procedure-related factors, there is a device-specific device-host interaction that explains aortic regurgitation after transcatheter aortic valve implantation.

Aims: We describe a new semi-automated method that measures aortic regurgitation (AR) on contrast aortography with the objectives of reducing the inter-observer variability and standardising image acquisition. Methods and results: Aortograms from three participating centres were reviewed to generate the following quality criteria: entire left ventricle and aortic root in view, descending aorta or TOE probe not over-projected, breath hold, no table motion, and adequate contrast opacification of the aortic root. AR was visually graded (Sellers) and was quantified by measuring the area under time-contrast density curves in the aortic root (reference) and the left ventricle. Quality criteria were met in 44 retrospectively identified aortograms and in 22 (69%) of 32 prospectively collected aortograms. The visual AR grade (Sellers) was highly correlated with time-density measurements including relative area under the curve (RAUC) and qRA index (r=0.81 and 0.83, respectively, p