Usability and accuracy of two different aortic annulus sizing software programs in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs 'Valve Assist 2' (GE Healthcare) and 3mensio 'Structural Heart' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users. METHODS: Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group. RESULTS: Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ2 (1) = 21.10, p < 0.001, φ = 0.579). CONCLUSION: The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.

Clinical utility of intraprocedural three-dimensional integrated image guided transcatheter aortic valve implantation using novel automated computed tomography software: A single-center preliminary experience.

OBJECTIVES: Novel automated computed tomography (CT) software (Valve ASSIST 2) has been developed for transcatheter aortic valve implantation (TAVI), which not only provides three-dimensional (3D) reconstruction of multidetector (MD) CT images, but also enables intraprocedural real-time fusion of fluoroscopic and MDCT images. We aimed to clarify the reproducibility and accuracy of this software in the aortic annulus assessment and verify the potential of intraprocedural integrated MDCT imaging for TAVI. METHODS AND RESULTS: We examined 50 patients with severe aortic stenosis undergoing transfemoral TAVI. Aortic annulus measurements were performed using 3mensio and the novel planning software. For intraprocedural imaging, preoperative CT dataset was overlaid onto fluoroscopy with the fusion software. The two images were aligned using the aortic root anatomy visible on both modalities. Novel planning software provided excellent reproducibility for the measurement of aortic annulus area (intraobserver intraclass correlation coefficients [ICC] 0.959, interobserver ICC 0.941), and perimeter (intraobserver ICC 0.915, interobserver ICC 0.912). Excellent correlation was found between novel planning software and 3mensio (ICC 0.952 for aortic annulus area, and 0.923 for perimeter). Intraprocedural fusion image of CT aortography and fluoroscopic aortic root aortography generated by this novel software identified coronary orifices and the distribution of aortic valve calcification during the device positioning. Fusion image displayed coronary orifices after device implantation. CONCLUSIONS: Novel planning software showed excellent reproducibility and accuracy in the assessment of aortic root anatomy. Furthermore, the integrated 3D fusion image might have a potential as an intraprocedural imaging modality to contribute to the development of a safer TAVI procedure.

Impact of N-terminal pro-B-type natriuretic peptide response on long-term prognosis after transcatheter aortic valve implantation for severe aortic stenosis and heart failure.

N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels prior to transcatheter aortic valve implantation (TAVI) are known to be associated with outcomes of patients undergoing TAVI. However, little has been known about the NT-proBNP response after TAVI. Therefore, we aimed to clarify the role of the NT-proBNP response and identify the determinants of the NT-proBNP nonresponse among patients with severe aortic stenosis (AS) and heart failure (HF) undergoing TAVI. We examined 717 patients with severe AS and HF undergoing TAVI. NT-proBNP nonresponders were defined as patients whose NT-proBNP levels decreased by ≤ 30%. Mean NT-proBNP levels decreased from 7698 ± 7853 pg/mL (baseline) to 4523 ±  5173 pg/mL (post-TAVI); 269 patients (38%) were nonresponders. Female gender and prevalence of diabetes mellitus (DM), chronic kidney disease (CKD), atrial fibrillation (AF), and history of coronary artery revascularization were more common for NT-proBNP nonresponders. Permanent pacemaker implantation rate was higher for NT-proBNP nonresponders. In addition to the baseline NT-proBNP level > 7500 pg/smL (hazard ratio [HR], 1.8; p = 0.03), NT-proBNP nonresponse (HR 2.3; p = 0.001) was associated with lower survival rates. Baseline NT-proBNP level ≤ 7500 pg/mL (OR 3.2; p < 0.001), female gender (odds ratio [OR], 1.5; p = 0.049), DM (OR 1.6; p = 0.016), CKD (OR 1.8; p = 0.001), AF (OR 2.4; p < 0.001), history of coronary revascularization (OR 1.7; p = 0.003), and permanent pacemaker implantation after TAVI (OR 1.7; p = 0.034) were independent determinants of NT-proBNP nonresponse. In "conclusion", NT-proBNP response is important for long-term survival after TAVI. We should consider the aforementioned determinants, particularly permanent pacemaker implantation, as risk factors for NT-proBNP nonresponse.

Predictors of permanent pacemaker implantation after transcatheter aortic valve implantation for aortic stenosis using Medtronic new generation self-expanding CoreValve Evolut R.

Conduction disturbance requiring permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve implantation (TAVI) using Medtronic self-expanding CoreValve, and has remained common following the introduction of the new generation CoreValve Evolut R device. The aim of this study was to identify the determinants of PPM implantation after TAVI with CoreValve Evolut R. We retrospectively examined 114 patients who underwent transfemoral TAVI using CoreValve Evolut R. We excluded 17 patients with preprocedural PPM, 1 patient requiring Edwards SAPIEN 3 implantation after CoreValve Evolut R implantation, and 4 patients who died during the hospital admission. Thus, 92 patients were finally included in the analysis. Seventeen patients (18%) underwent new PPM implantation after TAVI. Preprocedural electrocardiography showed a lower ventricular rate and more right bundle branch block (RBBB) in patients with new PPM implantation compared to those without. Quantitative multidetector computed tomography assessment revealed larger aortic valve calcification (AVC) and higher asymmetry (∆AVC) in patients with new PPM implantation compared to those without. The univariate logistic regression analysis demonstrated that preprocedural ventricular rate ≤ 70 beats per minute, RBBB, AVC ≥ 110 mm3, and ∆AVC ≥ 45 mm3 were associated with new PPM implantation. Number of these factors clearly stratified the risk of new PPM implantation. In conclusion, PPM implantation occurs in 18% of patients undergoing TAVI with the new generation CoreValve Evolut R. Lower preprocedural ventricular rate, RBBB, larger AVC, and higher ∆AVC are associated with new PPM implantation after TAVI using the new generation CoreValve Evolut R.

Different impact of aortic regurgitation assessed by aortic root angiography after transcatheter aortic valve implantation according to baseline left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide.

Transcatheter aortic valve implantation (TAVI) is an alternative therapeutic option for severe aortic stenosis. Aortic regurgitation (AR) is commonly observed after TAVI and increases the mortality rate. We hypothesized that the influence of significant AR, defined as that more severe than mild AR, on survival rate after TAVI might differ according to the baseline left ventricular ejection fraction (LVEF) and N-terminal pro-B-type natriuretic peptide (NT-pro BNP) level. We categorized 856 patients who underwent transfemoral TAVI into 2 groups according to their baseline LVEF (<40 and ≥40%) and NT-pro BNP levels (≤5000 and >5000 pg/mL). Significant AR was observed in 92 patients (11%). Among patients with significant AR, the proportion of patients with CoreValve/EvolutR implantation was higher than that of patients with SAPIEN XT/3 implantation. Kaplan-Meier curves and the log-rank test showed that significant AR was not associated with 1-year mortality in patients with LVEF ≥40% and those with NT-pro BNP level ≤5000 pg/mL. On the other hand, it was significantly associated with a higher 1-year mortality in patients with LVEF <40% (p = 0.003) and those with NT-pro BNP level >5000 pg/mL (p = 0.011). Similarly, multivariate Cox regression analysis showed that the presence of AR was significantly associated with a higher 1-year mortality in patients with LVEF <40% [p = 0.005, hazard ratio (HR) = 3.626] and NT-pro BNP level >5000 pg/mL (p = 0.004, HR = 3.221). However, AR was not significantly associated with a higher 1-year mortality in patients with LVEF ≥40% and NT-pro BNP level ≤5000 pg/mL. Thus, the impact of significant AR on mortality after TAVI seems to be considerable in patients with reduced LVEF or high NT-pro BNP levels, but not those with preserved LVEF or low NT-pro BNP levels, suggesting that the influence of AR differs depending on the baseline LVEF and NT-pro BNP level.

Predictors of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation for Aortic Stenosis Using New-Generation Balloon-Expandable SAPIEN 3.

Paravalvular regurgitation (PVR) is a common and serious complication after transcatheter aortic valve implantation (TAVI). New-generation balloon-expandable SAPIEN 3 has an outer sealing skirt to minimize PVR. However, the predictors of PVR after SAPIEN 3 transcatheter heart valve (THV) implantation have not been well investigated. We sought to clarify the determinants of PVR after TAVI using SAPIEN 3 with quantitative multidetector computed tomography (MDCT) assessment. This study analyzed 281 patients with severe symptomatic aortic stenosis who underwent TAVI using SAPIEN 3. Quantitative assessment of aortic root dimensions and calcium volume for leaflet, annulus, and left ventricular outflow tract were retrospectively performed with MDCT. MDCT nominal area oversizing was calculated using the following formula: % oversizing = (THV nominal area/MDCT derived annular area - 1) × 100. Logistic regression analysis was performed to determine the predictors of PVR greater than or equal to mild. PVR greater than or equal to mild was observed in 19% (53 of 281). Quantity and asymmetry of aortic valve calcium of annulus, left ventricular outflow tract, and leaflet were associated with higher incidence of PVR greater than or equal to mild, except leaflet asymmetry. Lower percentage of THV oversizing was also associated with PVR. Multivariable logistic regression analysis showed that larger calcification volume of annulus and lower percentage of THV oversizing were independent predictors of PVR greater than or equal to mild. These results suggest that prosthesis/annulus incongruence and aortic annulus calcification predicted PVR greater than or equal to mild after TAVI using SAPIEN 3.

Fibrinolytic Treatment after Transient Ischaemic Attack Caused by Prosthetic Mitral Valve Thrombosis.

Prosthetic valve thrombosis is one of the most severe complications after surgical valve replacement. There are many possible presentations: from asymptomatic to life-threatening complications. We report on a 61-year-old female patient with prosthetic replacement of the aortic and mitral valve in the in-house department of cardiac surgery 3 months ago. The patient was suffering from aphasia during 5 minutes in domesticity. After her presentation in the emergency room, the echocardiographic examination revealed a thrombotic formation of the prosthetic mitral valve. At presentation, the anticoagulation was outside the effective range (INR: 1.7). A successful thrombolytic therapy with the plasminogen activator urokinase was begun with complete resolution of the thrombus.