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

Determinants of image quality of rotational angiography for on-line assessment of frame geometry after transcatheter aortic valve implantation

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

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations

OBJECTIVE: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). METHODS: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. RESULTS: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. CONCLUSIONS: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s12471-021-01568-5) contains supplementary material, which is available to authorized users

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

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

Impact of baseline and newly acquired conduction disorders on need for permanent pacemakers with 3 consecutive generations of self-expanding transcatheter aortic heart valves

Introductions: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)). Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days. Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19–0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19–0.91, P-value = 0.028) were independently associated with less need for PPI. Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR

MitraClip after failed surgical mitral valve repair: an international multicenter study

BackgroundRecurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges.Methods and ResultsThis international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class >= III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of >= 1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class <= II.ConclusionsMitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.Cardiolog

Expanding the indications for transcatheter aortic valve implantation

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.Cardiolog

Reclassification of aortic stenosis by fusion of echocardiography and computed tomography in low-gradient aortic stenosis

Background The integration of computed tomography (CT)-derived left ventricular outflow tract area into the echocardiography-derived continuity equation results in the reclassification of a significant proportion of patients with severe aortic stenosis (AS) into moderate AS based on aortic valve area indexed to body surface area determined by fusion imaging (fusion AVA(i)). The aim of this study was to evaluate AS severity by a fusion imaging technique in patients with low-gradient AS and to compare the clinical impact of reclassified moderate AS versus severe AS. Methods We included 359 consecutive patients who underwent transcatheter aortic valve implantation for low-gradient, severe AS at two academic institutions and created a joint database. The primary endpoint was a composite of all-cause mortality and rehospitalisations for heart failure at 1 year. Results Overall, 35% of the population (n= 126) were reclassified to moderate AS [median fusion AVAi 0.70 (interquartile range, IQR 0.65-0.80)cm(2)/m(2)] and severe AS was retained as the classification in 65% [median fusion AVAi 0.49 (IQR 0.43-0.54) cm(2)/m(2)]. Lower body mass index, higher logistic EuroSCORE and larger aortic dimensions characterised patients reclassified to moderate AS. Overall, 57% of patients had a left ventricular ejection fraction (LVEF) = 50% (log-rankp= 0.029). Conclusions The integration of CT and transthoracic echocardiography to obtain fusion AVAi led to the reclassification of one third of patients with low-gradient AS to moderate AS. Reclassification did not affect clinical outcome, although patients reclassified to moderate AS with a LVEF <50% had worse outcomes owing to excess non-cardiac mortality.Cardiolog

Impact of Baseline and Newly Acquired Conduction Disorders on Need for Permanent Pacemakers With 3 Consecutive Generations of Self-Expanding Transcatheter Aortic Heart Valves

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)). Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days. Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19–0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19–0.91, P-value = 0.028) were independently associated with less need for PPI. Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR. © 2021 The Author(s

Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation

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 = 0.05). The embolized tissue originated from the native aortic valve leaflets, aortic wall, or left ventricular myocardium. On multivariable logistic regression analysis, balloon-expandable THVs (odds ratio: 7.315; 95% confidence interval: 1.398 to 38.289; p = 0.018) and cover index (odds ratio: 1.141; 95% confidence interval: 1.014 to 1.283; p = 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